BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1022678 · Received April 1, 2008

    Report

    Report Number
    1823260-2008-02903
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE CUSTOMER OBTAINED THE FOLLOWING BLOOD GLUCOSE COMPARISONS ON THE ACCU-CHEK AVIVA SYSTEM. 227 MG/DL AND 102 MG/DL; 102 MG/DL, AND 228MG/DL. THE CUSTOMER'S ACCU-CHEK AVIVA SYSTEM WAS ALSO COMPARED TO THE PROFESSIONAL METER WITH THE FOLLOWING BLOOD GLUCOSE COMPARISON 102MG/DL AND 200'S MG/DL. ALL AFOREMENTIONED TESTS WERE OBTAINED WITHIN 10 MINS. NO REPORTED SYMPTOMS/ACTIONS/TREATMENT. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT AND RETURNED 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 300555

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR LEVOTHYROXINE 3 YRS-1 PILL/DAY| CYMBALTA 60MG/DAY 3 YRS| AVANDAMET 2MG/DAY 3 YRS| METOPROLOL 200MG/DAY 3 YRS| AVAPRO 300MG/DAY - 3 YRS| LEVEMIR 22 UNITS/DAY - 2 WEEKS