BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1022380 · Received March 27, 2008

    Report

    Report Number
    1823260-2008-02794
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 437 MG/DL, 188 MG/DL, AND 347 MG/DL ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND 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 549529

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR HUMULIN N - 20 YEARS 20 UNITS/DAY| HUMULIN R - 20 YEARS 20 UNITS/DAY| "FEROUSEMAX" - 3 YEARS| VITAMIN E - 400MG/DAY| TYLENOL - YEARS| BABY ASPIRIN - YEARS 81MG/DAY| HYDROCHLOROTHIAZIDE - SEVERAL YEARS| IRON| VITAMIN D - 600MG/DAY