DDG: Medisana AG and Aldi Süd endanger patient safety
06.07.2016 10:42
The medical device manufacturer Medisana AG sold a batch of grossly unreliable blood sugar test strips through the discounter Aldi Süd. The Institute for Diabetes Technology Research and Development Company mbH at the University of Ulm (IDT) discovered the inaccuracy of the test strips. The results of the test laboratory may now be published in a specialist journal - the Berlin district court decided this on June 21, 2016, thus revoking an interim injunction by Medisana AG against publication. “This ruling strengthens the freedom of science,” says Professor Dr. med. Baptist Gallwitz, President of the German Diabetes Society (DDG). At the same time, Gallwitz criticized the fact that neither Medisana AG nor Aldi Süd had made any effort to recall the faulty test strips. “By failing to do so, Aldi Süd runs the risk of endangering patients’ lives,” states the DDG President.
At the beginning of the year, on its own initiative, the IDT tested blood glucose measuring systems with test strips of batch number R151018406 for measurement accuracy, which were manufactured by Medisana AG and sold in Aldi Süd branches under the product name “Curamed blood glucose meter model CM”. “We tested the strips on 100 patients with blood from their fingertips,” reports Dr. med. Guido Freckmann, Managing Director of the IDT and member of the board of the DDG Diabetes and Technology Working Group. “We proceeded strictly according to scientific standards.”
The tests were inadequate in terms of the required accuracy. “Especially in the low blood sugar range, the measured values were significantly too high and were suitable for concealing the threat of hypoglycemia,” explains Professor Dr. Lutz Heinemann, Chairman of the DDG Diabetes and Technology Working Group. The products stated values that were on average 16 percent higher. “This poses a risk to the patient, for example if the patient wants to start a car journey,” explains Heinemann. The IDT duly reported the results to Medisana AG and, at the end of March 2016, also to the Federal Institute for Drugs and Medical Devices (BfArM).
In May 2016, Medisana AG obtained an interim injunction from the Berlin Regional Court, according to which the “naming (…) and/or the distribution channel (…)” is prohibited on a scientific poster that presented the test results at the spring congress of the German Diabetes Society. The IDT then filed an objection against the interim injunction. On Tuesday, the Berlin Regional Court decided to uphold the objection. In the oral hearing, the content of which primarily revolved around the requirements of the ISO 15197 standard, the presiding judge stated: “A normal customer must be able to rely on the fact that the blood sugar measurement works.”
The German Diabetes Society welcomes the verdict of the Berlin district court. “But as much as we are pleased that the freedom of science is preserved with the judge’s ruling, we are astonished that neither Medisana AG nor Aldi-Süd started a recall of the unreliable test strips,” said Dr. Dietrich Garlichs, Managing Director of the DDG. Upon request, Aldi Süd told Bayerischer Rundfunk, which reported on the faulty test strips in a television report on June 9, 2016, that they had not yet had any information about possible health risks from the blood glucose meters.
This statement is incorrect. “We sent the Aldi Süd press office our press release about the poor test results by email on May 13, 2016 and made ourselves available to answer any questions,” said Garlichs. “Aldi Süd should have fulfilled its duty of care and inquired in the interests of patient safety.” However, at the latest with the request from Bayerischer Rundfunk, the discounter should have drawn conclusions and informed about the faulty test strips, Garlichs continued. “Looking the other way can cause great damage when it comes to medical devices, but transparency creates trust,” says the DDG managing director. To the astonishment of the specialist society, the supervisory authority, the Federal Institute for Drugs and Medical Devices (BfArM), has not yet commented on the measurement results.