Patient safety: Diabetes Society calls for recall of blood glucose test strips
The German Diabetes Association (DDG) accuses a manufacturer of health products and a chain of discounters of endangering patient safety by selling presumably unreliable blood glucose test strips. The products should be recalled.
Recall of blood glucose test strips and meter kits
People with diabetes need to check their blood sugar levels regularly. However, this becomes problematic when the devices required for this are faulty. The pharmaceutical company Stadapharm recently recalled measuring device kits and blood glucose test strips because measurement inaccuracies could occur when measuring with the affected products. This could lead to false low blood sugar levels and thus health risks for diabetics. Not all companies react as precautionary to identified problems and are therefore criticized.
Health hazards due to incorrect measurement results
The German Diabetes Association (DDG) accuses the medical technology manufacturer Medisana AG and the Aldi Süd retail chain of endangering patient safety by selling presumably unreliable blood glucose test strips. Indeed, there is a risk of incorrect measurement results. The problem of high blood sugar levels is usually known, but the risks of low blood sugar are often underestimated. And that despite the fact that hypoglycemia (hypoglycemia), according to doctors, is the much more common and also dangerous complication in diabetes mellitus. Signs of hypoglycaemia may include tremors, excessive sweating, restlessness or nervousness. In extreme cases, there is even danger to life for those affected.
Inaccuracy of the test strips found
A message from DDG states: “The medical device manufacturer Medisana AG has sold a batch of grossly unreliable blood sugar test strips through the discounter Aldi Süd. The Institute for Diabetes Technology Research and Development Corporation at the University of Ulm (IDT) determined the inaccuracy of the test strips. ”DDG President Professor Dr. med. Baptist Gallwitz criticized that neither Medisana AG nor Aldi Süd had made any efforts to recall the faulty test strips. "With this omission, Aldi Süd takes the risk of endangering patient life," says Gallwitz.
"This poses a patient risk"
At the beginning of the year, the IDT, on its own initiative, checked a test strip batch for the "Curamed blood glucose meter model CM" from Medisana. The self-test system is sold in the branches of Aldi Süd. The tests were poor in terms of the required accuracy. "Especially in the low blood sugar range, the measured values were clearly too high and were suitable for masking the risk of hypoglycaemia," explained Professor Dr. Lutz Heinemann, Chairman of the Diabetes and Technology Working Group at DDG. The products were said to have given values that were an average of 16 percent over-inflated. "This poses a risk to the patient, for example if the patient wants to start driving," warned Heinemann. The IDT reported the results to both Medisana AG and the Federal Institute for Drugs and Medical Devices (BfArM).
Customer must be able to rely on blood glucose monitoring
According to the information, Medisana then obtained an injunction from the Berlin Regional Court in May, after which the naming of the manufacturer or distribution channel in connection with the publication of the test results during the DDG spring conference was prohibited. The IDT then appealed the injunction. The Berlin Regional Court now decided to uphold the objection. At the hearing, the presiding judge stated: "A normal customer must be able to rely on the fact that the blood sugar measurement works." The DDG welcomes the verdict. "But as much as we are pleased that the freedom of science is preserved with the judge's decision, we are amazed that neither Medisana AG nor Aldi-Süd started a recall campaign for the unreliable test strips," said Dr. Dietrich Garlichs, managing director of DDG.
No knowledge of health hazards yet
On request, Aldi Süd told Bayerischer Rundfunk, which reported on the faulty test strips in a television report at the beginning of June, that so far they had no knowledge of possible health risks from the blood glucose meters. However, according to the DDG, this statement is incorrect. "We sent the press release from Aldi Süd on May 13, 2016 our press release about the poor test results and made ourselves available for questions," said Garlichs. "Aldi Süd should have fulfilled his duty of care and asked about patient safety." For the first time, the DDG explicitly called for an immediate recall of the unsafe test strips. This requirement will now be reaffirmed.
Risk assessment process initiated
According to the DDG, the discounter should have taken consequences and informed about the faulty test strips at the latest with the request of the Bavarian Broadcasting Corporation, says Garlichs: "Looking away can cause great damage to medical devices, transparency, on the other hand, creates trust." that the BfArM has not yet commented on the measurement results. BfArM spokesman Maik Pommer, however, informed a request from the "Ärzte Zeitung" that a risk assessment procedure had been initiated at the end of March, immediately after information from the IDT. The authority would carry out a further assessment of the case and provide information after the results were available. (ad)