Posts Tagged ‘Insulin’

Potentially Fatal Errors with Certain Glucose Test Strips

Thursday, October 8th, 2009

Video originally created by FDA -- posted by Lawsuit.com on October 6, 2009

FDA is warning again that potentially fatal glucose monitoring errors can occur in patients who receive therapeutic products containing certain sugars other than glucose. These products include oral xylose, intravenous infusions that contain maltose or galactose, and peritoneal dialysis solutions that contain icodextrin, such as Extraneal. A more specific product list can be found below.

The problem is that some glucose meters use a type of test strip (GDH-PQQ) that cannot distinguish between glucose and these other sugars, so the reading on one of these test strips will reflect both the patient’s actual blood glucose and the other sugar the patient received. These falsely elevated readings can mask significant hypoglycemia, or they can lead to excessive insulin administration. This can result in severe hypoglycemia, coma and death. Other glucose test strip methodologies are not affected by the presence of non-glucose sugars.

FDA has received 13 reports of deaths associated with GDH-PQQ test strips that had documented interference from maltose or other non-glucose sugars. The deaths occurred in healthcare facilities. Ten of the 13 patients were receiving Extraneal peritoneal dialysis solution for renal failure. Three of the 13 patients were receiving maltose-containing substances. Patients were treated with insulin doses or insulin drips that were guided by falsely elevated blood sugar results. Six of the 13 deaths have occurred since 2008, despite previous warnings from FDA and others.

FDA is now recommending that healthcare facilities avoid using GDH-PQQ glucose test strips, which include several types of ACCU-CHEK, TRUEtest and Freestyle test strips.

If a facility does use GDH-PQQ test strips, FDA recommends additional precautions:

• Determine whether patients are receiving products that contain other sugars when they are admitted and periodically during their stay at the facility.

• If patients are receiving one of these interfering products, never use GDH-PQQ test strips to monitor their blood glucose. Instead, use only laboratory-based glucose assays. This also holds true for patients who are unresponsive or cannot communicate adequately.

• Educate the staff about this potentially fatal problem, and consider safeguards such as drug interaction alerts in computer order entry systems, patient profiles and charts. And for patients who are not receiving interfering products, periodically verify glucose meter readings with laboratory-based results.

FDA is working with glucose monitoring manufacturers to address problems with GDH-PQQ glucose test strips, and will continue to monitor adverse events associated with these products.

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Recall of ReliOn Insulin Syringes (Jan. 2009)

Thursday, January 15th, 2009

Video originally created by FDA -- posted by Lawsuit.com on January 14, 2009

Covidien, formerly Tyco Health Care, has recalled one lot of ReliOn disposable insulin syringes because of mislabeling. Some of the U-40 syringes in this lot were mistakenly labeled as U-100 syringes. Patients using U-100 insulin could experience a serious overdose if they used one of these mislabeled U-40 syringes, and that could lead to severe hypoglycemia and possibly death.The recalled lot is number 813900. These 1 cc, 31 gauge insulin syringes, which were mistakenly labeled U-100, were sold only by Wal-Mart and Sam’s Club, under the ReliOn name, from August 1 to October 8, 2008.FDA is urging healthcare professionals and patients to check their supplies of U-100 insulin syringes for the recalled products and not use them. The recalled syringes can be returned to Wal-Mart or Sam’s Club for replacement.

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New Drug to Treat Type 1 and Type 2 Diabetes (May 2005)

Tuesday, December 9th, 2008

Video originally created by FDA -- posted by Lawsuit.com on July 14, 2008

FDA recently approved a new injectable drug to help control blood sugar in adult patients with Type 1 and Type 2 diabetes. It’s called Symlin, or pramlintide acetate, and it’s manufactured by Amylin Pharmaceuticals.Symlin is used in addition to insulin to help reduce postprandial blood sugar levels in patients who can’t achieve adequate control despite optimal insulin therapy. Tighter control of blood sugar may help reduce the risk of long-term renal, cardiovascular and ocular events in these patients.Although patients with Type 2 diabetes already have drug therapy other than insulin to help control blood sugar, Symlin will be the only therapy available other than insulin for Type 1 patients.The FDA and the manufacturer have some safety concerns about Symlin. First, the drug may increase the risk of hypoglycemia. This risk is greatest in Type 1 diabetics and in those with gastroparesis. Second, patients might mix Symlin with insulin in the same syringe, which can alter the activity of the insulin. And third, the drug might be used inappropriately in patient populations where the risk / benefit profile hasn’t been established.To help resolve these concerns, FDA is requiring that patients receive a Medication Guide with each prescription that explains the risks and how to use the drug properly.The guide tells patients they must be using their insulin as prescribed, must follow their doctor’s instructions on using the drug, must be followed up frequently, and that they must test their blood sugar before and after every meal and at bedtime.The labeling for physicians will specify that Symlin not be used in patients with gastroparesis, or those allergic to any of the drug’s ingredients.

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Potential Problems with Insulin Pens in Hospitals (August 2008)

Tuesday, August 5th, 2008

In a recent article, the Institute for Safe Medication Practices (ISMP) highlighted several potential safety problems when hospitals switch from multiple dose vials of insulin to insulin pens.

ISMP points out that there are certain safety advantages in using the pens. For example, the pens may reduce the chance of drug mix-ups, since each pen is pre-labeled with product name and strength, and the patient’s name can be on the label as well. But ISMP also notes a number of potential safety problems to watch out for when hospitals switch to pens.

One possible problem is needlestick injuries, which could happen because the pen may make it difficult to see the injection site. Also, some needles do not have needle guards, so a needlestick can occur after the injection.

Another difficulty is that part of the insulin in the pen may not be delivered. This can happen because the buttons on some pens are difficult to push down, making it easy to accidentally lift the needle out of the skin during the injection. There can also be leakage around the injection site if the needle is not left in place for at least six seconds after the injection. In addition, uneven dosing of an insulin suspension can occur if the user fails to tip and roll the pen before the injection, causing the suspension to clump.

Sometimes nurses unfamiliar with a particular type of pen will use it as a multiple-dose vial, withdrawing insulin from the pen cartridge with a sterile needle and a conventional insulin syringe. This is not recommended, because aspirating insulin from the cartridge can leave air pockets. When the cartridge is used again, these air pockets can cause dosing errors or air injection.

Another problem is using the same pen for multiple patients, which is potentially hazardous. Attaching a new sterile needle to the pen before using it on another patient cannot solve the problem. That’s because the insulin inside the pen’s cartridge can become contaminated with biological material after the first injection, while the original needle is still on the pen.

Finally, the design of some pens can lead to dosing errors. For example, in some cases the digital display of the dose can be mis-read if a person holds the pen upside down, as a left-hander might do. In that case, a dose of 21 units looks like 12.

How can these problems be avoided? ISMP says that the key is to prepare for the transition to pens. That means understanding and anticipating the risks beforehand, doing a failure mode and effects analysis, educating the staff about using the pens properly, and closely monitoring their use for the first few months of the transition. ISMP recommends that written guidelines be developed for each type of pen used in the hospital, with specific instructions on handling the pens safely, injection techniques, and prohibitions on sharing pens or using them as multiple dose vials.

Additional Information:

ISMP Medication Safety Alert. Considering Insulin Pens for Routine Hospital Use? Consider This…Volume 13, Issue 9. May 8, 2008.
http://www.ismp.org/Newsletters/acutecare/articles/20080508.asp

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