BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1761134 · Received July 19, 2007

    Report

    Report Number
    1823260-2007-06310
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    June 30, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 261 MG/DL AND 121 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 300282

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR HYDRALAZINE 25 MG TWICE DAILY| LEVOTHYROID 5MG DAILY| MEVACOR 20MG 2 DAILY| FOLIC ACID 1MG DAILY| FUROSEMIDE 25MG DAILY| ALBUTEROL INHALER DOSE UNK| ASPIRIN 81MG DAILY| CLONAZEPAM 0.5MG TWICE DAILY| LYRECKER 75MG TWICE DAILY| KLORCUM 10MG DAILY