FDA weighs dangers of faulty readings from blood clot monitors

The FDA is considering possible dangers from medical devices that monitor blood clotting producing false readings, according to a report from The Wall Street Journal.

The FDA has tracked thousands of cases of malfunctions from such devices over the years, the WSJ reports. Deaths and serious injuries have been linked with the erroneous readings, due to the increased susceptibility of individuals on anticoagulant drugs to strokes and other dangerous events.

The federal watchdog brought together a panel of experts to discuss “point of care” clotting monitors last Friday to try and analyze the extent of the problem and help encourage more accurate product development, the WSJ said.

The paper reported that the FDA said “serious adverse events” appear to be “linked to inaccurate performance” of the devices, linking 18 deaths in 2014 and 2015 to the faulty readings.

The issue is under examination after the INRatio blood clot monitoring device from Alere (NYSE:ALR), used in a study to approve an anticlotting drug in 2011, was recalled after it was determined that the device “may provide” incorrect results, The Wall Street Journal said.

Alere issued the recall last January after concerns that the inaccurate results could result in serious injury or death.

According to the FDA’s website, Alere issued a recall Dec. 5, 2014 for its INRatio and INRatio2 monitors and test strips after receiving reports the devices failed to accurately measure a patient’s international normalized ratio, or INR. The products are used to determine the blood-clotting speed, or prothrombin time, in patients taking the anticoagulant drug warfarin.

The agency added that the readings were more likely to be inaccurate if the patient also had anemia, unusual bruising/bleeding or a condition associated with elevated fibrinogen levels.

Alere has received 18,924 reports of the devices malfunctioning, including 14 reports of serious injury. The company has determined that all of the devices are at risk of failing, according to the FDA.

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