Warning
1998-48
July 31, 1998
Certain Lifescan Surestep Glucose Meters recalled
OTTAWA - Health Canada is advising consumers of a recall of certain SureStep Glucose Meters which may display an error message instead of a valid reading. When used to read blood glucose levels, the affected meters may give an error message ("Er-1") instead of a high blood glucose reading ("HI"), when glucose levels are very high (greater than 27.8 mmol/L).
Diabetics monitoring their blood sugar may not be aware that their blood sugar is dangerously high and, as a result, may fail to seek prompt medical attention.
The problem is confined to SureStep Glucose Meters manufactured before August 1997 with the serial number L6000 XX XXXXX through L7205 XX XXXXX.
The product, sold to consumers through pharmacies and hospitals, is distributed across Canada by Lifescan Canada Inc. of Burnaby B.C. The name Lifescan SureStep appears on the device.
In the United States, there have been reports of deaths of two individuals with very high blood glucose levels who, after repeated error messages from their glucose meters, delayed seeking medical treatment.
A recall has been voluntarily initiated by Lifescan Canada, who will replace the affected glucose meters. Consumers should contact LifeScan's Customer Service Line at 1-888-534-9991 to arrange for replacement.
Diabetics using the affected meters should be aware that an "Er-1" message may actually mean a very high level of blood sugar, instead of an error. In such instances, they should compare the blue colour dot on the test strip to the colour chart on the test strip bottle. If the colour is as dark or darker than the darkest oval on the colour chart, they should seek immediate medical advice.
Health Canada has received no similar problem reports for this product. Individuals with diabetes are urged to continue to monitor their blood glucose levels as recommended by their health care professional. Health Canada continues to monitor the effectiveness of the recall.
LifeScan is attempting to contact all registered users of the affected model of SureStep to provide a free replacement. In addition, the company has notified doctors, pharmacists and diabetes educators who may be in contact with individuals who use this model of blood glucose meter.
Media inquiries:
Dr. William Freeland
Health Canada
(613) 954-0298
Cellular: (613) 769-0857
Public Inquiries:
(613) 957-2991
|
