BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURE 4 BLOOD GLUCOSE TEST STRIPS

    MDR report key: 1081666 · Received July 24, 2008

    Report

    Report Number
    1832816-2008-00022
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 26, 2008
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    NBW
    PMA / PMN Number
    K070088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 1

    CALLER INDICATED THE ASSURE 4 METER WAS READING HIGH. IN 2008, HE WAS SYMPTOMATIC FOR HYPOGLYCEMIA, HIS BLOOD SUGAR WAS 65, GLUCAGON WAS GIVEN AND HE RESPONDED WITHOUT THE PARAMEDICS BEING CALLED. ON FIVE DAYS LATER, HIS BLOOD SUGAR READ 66 AND THE PARAMEDICS READ IT AT 24 ON THEIR MACHINE. PATIENT WAS TREATED AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASSURE 4 BLOOD GLUCOSE TEST STRIPS BLOOD GLUCOSE TEST STRIPS NBW APEX BIOTECHNOLOGY CORP. 560050 SS006K

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention