BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURE 4 BLOOD GLUCOSE SYSTEM

    MDR report key: 2618374 · Received June 15, 2012

    Report

    Report Number
    1832816-2012-00058
    Event Type
    Injury
    Date Received
    June 15, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    NBW
    PMA / PMN Number
    K070088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED IN INCIDENT WAS RETURNED, BUT THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER HAS COSMETIC DAMAGE, HOWEVER THIS DID NOT AFFECT PRODUCT PERFORMANCE. THE RETURNED METER WAS EVALUATED WITH RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT AND PERFORMED TO SPECIFICATION. NO PERFORMANCE FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE ASSURE 4 METER WAS GIVING VARIABLE READINGS. AT 7:30 AM TOOK READING ON METER AND THE RESULTS WERE 67 MG/DL. AT 7:31 AM WITH SAME METER AND NEW TEST STRIP THE RESULTS WERE 289 MG/DL. NURSE LISA ADMINISTERED INSULIN TO THE RESIDENT. UNABLE TO DETERMINE ANY USER ERROR. CALLER STATED THAT THE RESIDENT IS FEELING FINE AT THIS TIME. FACILITY DOES NOT HAVE CONTROLS, I HAVE URGED THEM TO GET SOME PLUS EXTRA FOR EMERGENCY SITUATIONS, AND TO KEEP THIS ITEM STOCKED AT ALL TIMES. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASSURE 4 BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW APEX BIOTECHNOLOGY CORP. 560001 SS054P

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening