BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU CHEK AVIVA TEST STRIPS

    MDR report key: 1052289 · Received May 23, 2008

    Report

    Report Number
    1823260-2008-04284
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE AVIVA SYSTEM WITH RESULTS OF 207MG/DL, 125MG/DL, 188MG/DL AND 346MG/DL. NO QUALITY CONTROLS WERE RUN DURING THE CALL. NO ADVERSE EVENT REPORTED. WIFE REPORTS THERE ARE NO STRIPS LEFT; A 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 301161

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR LANTUS 100 UNITS PM| HUMULIN REG SLIDING SCALE| LANTUS 60 UNITS AM