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Diabetes experts call for another recall of unreliable blood glucose test strips
The German Diabetes Association (DDG) accuses a manufacturer of health products as well as a discount chain, by the sale of suspected unreliable blood glucose test strips to endanger the safety of patients. The products should be recalled.
Recall of blood glucose test strips and meter kits
People with diabetes must regularly check their blood glucose levels. However, this becomes problematic if the necessary equipment is faulty. Only recently, the pharmaceutical company Stadapharm recalled meter kits and blood glucose test strips, as it could lead to measurement inaccuracies in the measurement of the affected products. This could lead to low blood sugar levels and thus to health hazards for diabetics. Not all companies respond to identified problems so precautionary and therefore get into the criticism.
The German Diabetes Society accuses the medical device manufacturer Medisana AG and the retail chain Aldi Süd of jeopardizing patient safety by selling suspected unreliable blood glucose test strips. (Image: Kzenon / fotolia.com) Health hazards due to incorrect measurement results
For example, the German Diabetes Association (DDG) accuses the medical device manufacturer Medisana AG and the Aldi Süd retail chain of endangering patient safety by selling suspected unreliable blood glucose test strips. Incorrect measurement results in danger. Although the problem of high blood sugar levels is usually known, the risks of low blood sugar are often underestimated. And although the hypoglycemia (hypoglycaemia) According to medical practitioners, the far more common and also dangerous complication in diabetes mellitus form. Signs of low blood sugar levels may include tremors, excessive sweating, inner restlessness or nervousness. In extreme cases there is even a danger to the person concerned.
Inaccuracy of the test strips detected
A statement by the DDG states: "Medical device manufacturer Medisana AG has distributed a batch of roughly unreliable blood glucose test strips via the discounter Aldi Süd. The inaccuracy of the test strips was determined by the Institute for Diabetes Technology Research and Development Company mbH at the University of Ulm (IDT). "DDG President Professor Dr. med. med. Baptist Gallwitz criticized that neither Medisana AG nor Aldi Süd had made efforts to recall the faulty test strips. "By doing so, Aldi Süd runs the risk of endangering patient life," says Gallwitz.
"This is a patient hazard"
At the beginning of the year, the IDT had reviewed on its own initiative a test strip lot for Medisana's Curamed Blood Glucose Meter Model CM. The self-test system is distributed in the branches of Aldi Süd. In terms of the required accuracy, the tests were poor. "Especially in the low blood sugar range, the measured values were clearly too high and were suitable to disguise an imminent hypoglycaemia", explained Professor Dr. med. Lutz Heinemann, chairman of the DDG consortium diabetes and technology. The products were said to have reported values that were on average 16 percent higher. "This is a patient hazard, for example, if the patient wants to start a drive," 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, in May Medisana obtained a preliminary injunction from the district court of Berlin, according to which the naming by manufacturer or distribution channel in connection with the publication of the test results was forbidden during the spring congress of the DDG. The IDT then filed an appeal against the injunction. The Berlin district court decided to grant the opposition. At the hearing, the presiding judge stated: "A normal customer must be able to rely on the blood sugar measurement to work." The DDG welcomes the verdict. "However, as much as we are pleased that the freedom of science is preserved with the judge's verdict, so much are we surprised that neither the Medisana AG nor Aldi-South started a recall of the unreliable test strips," said dr. Dietrich Garlichs, Managing Director of the DDG.
No findings on health hazards
Aldi Süd had told the Bayerischer Rundfunk, which reported on the faulty test strips in a TV report in early June, on request that they had so far no information on possible health hazards of the blood glucose meters. But this statement is incorrect according to DDG. "We sent our press release about the bad test results to the press office of Aldi Süd on May 13, 2016 via e-mail and made ourselves available for queries," says Garlichs. "Aldi Süd would have to fulfill its due diligence and inquire in terms of patient safety." The DDG called for the first time for the first time a prompt recall of the uncertain test strips. This demand will now be reaffirmed.
Risk assessment procedure initiated
According to DDG, the discounter would have had to take consequences at the latest with the inquiry of the Bayerischer Rundfunk and inform about the faulty test strips, Garlichs said: "Looking away can cause great harm to medical devices, transparency, however, creates confidence." The professional society expressed her "astonishment" about it, that the BfArM has so far not commented on the results. BfArM spokesman Maik Pommer, however, informed a request of the "Ärzte Zeitung" that a risk assessment procedure had been initiated at the end of March, immediately after being informed by the IDT. The authority will make a further assessment of the case after the results are available and inform it. (Ad)