A Medical Device Daily
MRL (Buffalo Grove, Illinois), a Welch Allyn (Skaneateles Falls, New York) business, reported that it has initiated a voluntary worldwide recall of 597 AED20 automatic external defibrillators (AEDs) manufactured in Buffalo Grove from February through July of last year.
The AED20 may display a “Defib Comm” error message on the device display during use, MRL said, “resulting in the device’s failure to analyze the patient’s ECG and deliver the appropriate therapy.” The problem, it said, occurs when an impact to the exterior of the AED20 causes a circuit board connector to perforate an insulation shield enabling an electrical short between the connector and the external housing.
The company reported receiving 12 related complaints with this group of AED20s, including one instance in which the short may have prevented patient resuscitation. “This represents 2% of the 597 recalled devices,” MRL said. The company said it has taken “corrective action” and that no other devices besides those manufactured between February-July 2004 are subject to recall.
MRL said it initiated notification by certified mail on May 5 to those who purchased this group of AED20s, 296 of which were sold within the U.S., 301 in other countries.
The company said it is providing customers with a loaner AED20 at no cost while their units are being serviced and will pay all costs associated with shipping, handling and corrective service.
The recall is being conducted with the FDA’s knowledge, MRL said, with the agency categorizing it as a Class 1 recall, meaning a probability that the problem may lead to adverse consequences or death.
LifeScan (San Jose, California), a maker of blood glucose test systems for diabetes, said it has launched “a worldwide notification” concerning its OneTouch Ultra, InDuo and OneTouch FastTake Meters, saying that users “may misinterpret their blood glucose results.”
All three meters are designed to allow patients to select one of two units of measure to display test results, with the selection typically determined by the standard used by the country where they live.
LifeScan said it is possible to accidentally change the unit of measure and thus result in misinterpretation of the results. In addition, it said, “very rarely, an event such as dropping a meter while in use can cause a brief power loss, which may also unexpectedly change the unit of measure and/or the code number used to program the meter to match a particular vial of test strips.”
The company said it is instructing patients to confirm their meter’s unit of measure and the code number each time they test.
From early 2004 through mid-March 2005, LifeScan reported receiving 40 worldwide reports of adverse events as a result of meters set to the incorrect measures. The events, it said, generally consisted of temporary periods of high or low blood sugar, some requiring medical attention.
There are an estimated 4.7 million users of these products worldwide, LifeScan said, with the products distributed primarily through retail pharmacy and mail order channels. Test strips for these systems are not affected, the company said.
The notification consists of letters to users and healthcare professionals and instructions inserted in each test strip package and that it has notified the FDA and other regulatory agencies worldwide concerning the problem.
The company said it “temporarily” has stopped shipment of versions of the OneTouch Ultra, OneTouch Fast-Take and InDuo Systems that allow users to change the unit of measure, and is implementing a product modification for its new OneTouch Ultra Meters that will prevent users from inadvertently switching their meter’s unit of measure.
It said shipments of the OneTouch Ultra Meters with this modification are expected to begin this week. It added that the timing to resume shipments of InDuo and OneTouch FastTake Meters has not been determined.