BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1172522 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07043
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACCU-CHEK AVIVA SYSTEM WITHIN 10 MINUTES: " HI" (GREATER THAN 600 MG/DL), 206MG/DL 189 MG/DL, AND 199 MG/DL. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. 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 301376

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR NOVOLIN (UNK TYPE) 3 YEARS| POTASSIUM| LASIX| COUMADIN| OMEPRAZOLE| METOPROLOL| PLAVIX| LISINOPRIL| CALCIUM - 7 YEARS