BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1172555 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07011
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACCU-CHEK AVIVA SYSTEM WITHIN 10 MINUTES: 105 MG/DL, 58 MG/DL, AND 56 MG/DL. THE CUSTOMER FELT DIZZY AND WEAK. SHE TREATED HERSELF BY EATING HALF OF A BANANA AND DRINKING TEA. SHE STATES THAT SHE MAY HAVE FELT BETTER 2 HOURS AFTER TREATMENT. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 301067

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR "VENLAFAIXN HCL"| AMBIEN| LANTUS