BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771965 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08166
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    August 17, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER REPORTS BACK-TO-BACK TESTING ON THE SAME METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF 227MG/DL AND 47MG/DL. NO QUALITY CONTROLS WERE RUN. 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 549909

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HUMALOG - 1 MONTH| SOMA - 325MG DAILY, 1.5 MONTHS| LORTAB - 7.5MG 3X/DAY, 1 YEAR| GLUCOPHAGE - 2MG DAILY, 4 MONTHS