BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1220884 · Received October 29, 2008

    Report

    Report Number
    2939301-2008-02858
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Report Date
    October 13, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND TEST STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATED IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRALINK METER WOULD NOT POWER OFF AND THE LAST RESULT WAS FROZEN. IT IS NOT KNOWN WHEN THE ALLEGED METER ISSUE BEGAN. HOWEVER, THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF SHAKINESS BEFORE THE ALLEGED METER ISSUE BEGAN. THE PATIENT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE ALLEGED METER ISSUE. SHE ALSO DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: WHEN THE ALLEGED METER ISSUE BEGAN, WHAT ACTIONS THE PATIENT TOOK IN RESPONSE TO DEVELOPING THE SYMPTOMS, HOW LONG THE PATIENT HAD THE SYMPTOMS FOR, AND IF SHE WAS ABLE TO TREAT OR RELIEVE THE SYMPTOMS. REMOVING AND RESEATING THE DEVICE'S BATTERY TEMPORARILY RESOLVED THE ALLEGED METER ISSUE. THE METER AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED POWER ISSUE THAT WAS TEMPORARILY RESOLVED. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED METER ISSUE CONTRIBUTED TO THE PATIENT'S SYMPTOMS/INJURY. THE PATIENT CLAIMED THAT HER SYMPTOMS DEVELOPED BEFORE THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2847894

    Patients

    Seq Age Sex Outcome Treatment
    1