BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STIRPS

    MDR report key: 844940 · Received March 1, 2007

    Report

    Report Number
    1823260-2007-01765
    Event Type
    Malfunction
    Date Received
    March 1, 2007
    Date of Event
    February 12, 2007
    Report Date
    March 1, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE: COMFORT CURVE TEST STRIPS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 180MG/DL, 212MG/DL, 258MG/DL, 463MG/DL, 279MG/DL, 123MG/DL, 163MG/DL, AND 509MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE TEST SYSTEM. NO ACTION WAS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. NO INFO PROVIDED ON LOCATION OF COMPARISON. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 549608, EXP 04/30/08. CAT/2030381.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STIRPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS * 549608

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR NITRO QUICK - 10 YEARS AS NEEDED| SPIRONOLACTONE - 10 YEARS, 25MG/1PILL| HUMALOG - 10 YEARS AS NEEDED| GLYBURIDE, 10 YEARS, 5MG/1PILL| HUMULIN - 10 YEARS AS NEEDED| WARFARIN - 10 YEARS, 5MG/2 1/2 TO 5 PILLS| INSULIN - 10 YEARS AS NEEDED.| AMIODORONE - 3 WEEKS, 4 PILLS/200MG EACH| FUROSEMIDE - 10 YEARS, 40MG/1PILL| LISINOPRIL, 10 YEARS, 20MG/1PILL| LEVOTHROID, 10 YEARS, 50MG/1PILL