BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUCOMETER DEX TEST SENSORS

    MDR report key: 139985 · Received December 23, 1997

    Report

    Report Number
    1810909-1997-00018
    Event Type
    Other
    Date Received
    December 23, 1997
    Date of Event
    December 1, 1997
    Report Date
    December 19, 1997
    Manufacturer
    BAYER CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN HOUSE EVALUATION OF MANY LOTS OF DISTRIBUTED SENSORS FOR THE DEX BLOOD GLUCOSE MONITOR HAS INDICATED THAT SEVERAL LOTS WILL NOT MEET CLAIMS THROUGH OUT THE SHELF LIFE. THESE LOTS ARE EXPECTED TO YIELD AN INCREASING FREQUENCY OF HIGH RESULTS WHICH MIGHT LEAD TO EXCESSIVE MEDICATION. LOTS 1A075AA,2A076AA,1A077AA,1A078AA, AND 1A078BA ARE BEING RECOVERED IN THE US, AND OTHER LOTS IN THIRTEEN OTHER COUNTRIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER DEX TEST SENSORS SENSORS FOR BLOOD GLUCOSE MONITOR CFR BAYER CORP. 3610 1A075AA,2A076AA,1A077AA,(MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other