BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1083335 · Received July 25, 2008

    Report

    Report Number
    1823260-2008-05798
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES. 219 MG/DL, 222 MG/DL, 219 MG/DL, 222 MG/DL, 223 MG/DL, 220 MG/DL, 189 MG/DL, 138 MG/DL, 109 MG/DL, 211 MG/DL, 205 MG/DL, AND 73 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 301231

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR SIMVASTATIN 80 MG 1/DAY| LISINOPRIL 2.5MG 1/DAY| ASPIRIN 81MG 1/DAY| WARFARIN 2MG TAKEN AT NIGHT| GLIPIZIDE 5MG