BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1022340 · Received March 27, 2008

    Report

    Report Number
    1823260-2008-02823
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYS WITHIN 10 MINS: 241 MG/DL, 87 MG/DL, AND 59 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 300916

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR LISINOPRIL 25MG 1/DAY - 3 YEARS| SYNTHROID 88 "MG" 1/DAY - 25 YEARS| "ASPART" NOVOLOG PUMP - 18 YEARS| NORVASC 5MG ONCE DAILY - 3 YEARS| LIPITOR 20MG 1/DAY - 1 YEAR| "HYDROCHLORIZIDE" 25MG - 3 YEARS| COZAAR 10MG ONCE DAILY - 3 YEARS