BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE 4 BLOOD GLUCOSE SYSTEM

    MDR report key: 1930640 · Received December 16, 2010

    Report

    Report Number
    1832816-2010-00035
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 6, 2010
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    CGA
    PMA / PMN Number
    K070088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE ALSO TESTED AND PERFORMED TO SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE ASSURE 4 METER WAS READING HIGH. AT AROUND 6 PM, NURSE TOOK BG OF PT. THE METER CAME BACK WITH A READING OF 500. THEY FELT THIS WAS TOO HIGH SINCE THE PT FELT FINE. THEY RETESTED WITH ANOTHER METER AND THE BG WAS 89MG/DL. NO TREATMENT GIVEN. CONTROL SOLUTION TESTS WERE WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASSURE 4 BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM CGA APEX BIOTECHNOLOGY CORP. 560050 SS042J

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR