FDA recalls glucose test strips sent to military hospitals
YOKOSUKA NAVAL BASE, Japan — Military medical officials in the Pacific are trying to reach some 700 patients who might be using faulty glucose test strips to measure their blood sugar levels.
Abbott Diabetes Care glucose test strips sent by the Defense Department to hospitals in the Pacific were among the 359 million strips identified in a recall announced last week by the U.S. Food and Drug Administration.
About 200 patients at U.S. Naval Hospital Yokosuka clinics, 457 patients at Okinawa bases and 47 patients at Misawa Air Base were among those affected by the recall, officials said Tuesday. The hospitals are calling patients and distributing recall information.
In Europe, military medical officials also are notifying diabetics about the recall, according to Europe Regional Medical Command. During the past six months, 6,626 boxes of 50ct Precision Xtra strips were dispensed to 1,308 patients at health facilities within the European military community, according to ERMC.
The recall was issued after results showed that the strips might report inaccurately low blood glucose levels, according to the FDA.
“False results may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading,” according to the FDA statement. “Both scenarios pose risks to a patient’s health.”
In a news release announcing the recall, the FDA warned customers to pay close attention to signs of high and low blood sugar, which can take many forms and can include excessive thirst, abdominal pain, trembling, and shortness of breath. However, some individuals may have no symptoms at all before they develop unconsciousness or seizures, according to the FDA.
Patients who fail to treat elevated blood glucose levels can develop diabetic ketoacidosis, which is fatal if untreated, according to the Mayo Clinic website.
The recall affects Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose strips. The test strips are available over-the-counter in the United States, but distributed by prescription at base hospitals in the Pacific.
Patients who are unable to get replacements have been issued guidelines for using the potentially faulty strips. The guidelines are available through base hospitals or at www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm237824.htm.
“We don’t want patients to stop testing, just to use the precautions outlined in the FDA [statement],” said Lt. Cmdr. Tiffany Cline, Yokosuka’s pharmacy department head.
If the strips prove faulty after the guidelines are followed, patients should contact their health care providers for alternative testing.
Affected hospitals are working on obtaining new lots of test strips, military officials said Tuesday.
To check if a specific strip packet is being recalled, check the lot number at the bottom of the box and go to www.precisionoptiuminfo.com, or call Abbott customer service at 1-800-448-5234.