BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1061143 · Received June 13, 2008

    Report

    Report Number
    1823260-2008-04721
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 11, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS BACK TO BACK COMPARISONS TO THE LAB WITH RESULTS OF HI (>600 MG/DL) ON THE METER AND 136 MG/DL AT THE LAB WHILE USING THE INFORM SYSTEM. CALLER REPORTS PT WAS NOT TREATED BASED ON THE RESULTS. CALLER REPORTS L1 AND L2 QUALITY CONTROLS WERE RUN AND IN RANGE. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS CORP. 550057

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK