BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK CONFORT CURVE TEST STRIPS

    MDR report key: 1141427 · Received September 3, 2008

    Report

    Report Number
    1823260-2008-05498
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    June 12, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S HUSBAND REPORTS BACK TO BACK COMPARISON OF METER TO LAB WHILE USING THE COMPACT SYSTEM WITH RESULTS OF 115MG/DL ON THE METER AND 70MG/DL AT THE LAB. NO CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. HUSBAND REPORTS CUSTOMER NO LONGER HAS STRIPS; A REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR DIABETES PILL