BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 860540 · Received March 7, 2007

    Report

    Report Number
    1823260-2007-01960
    Event Type
    Malfunction
    Date Received
    March 7, 2007
    Date of Event
    February 8, 2007
    Report Date
    March 7, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 500MG/DL AND 70MG/DL ON THE ADVANTAGE TEST SYSTEM WITHIN 10 MINUTES. CUSTOMER STATES THEY TOOK 20 UNITS OF N INSULIN AFTER THE RESULT OF 500MG/DL. NO ADVERSE EVENT REPORTED. NO QUALITY CONTROLS WERE USED. INFO SUGGESTS COMPARISON WAS PERFORMED IN THE HOME. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. ADVANTAGE TEST SYSTEM: STRIP LOT 549222, EXP 10/31/07, CAT/2030365.

    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 * 549222

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR NITROGLYCERIN - AS NEEDED| METOPROLOL - 25MG 3PILLS/3X A DAY| HUMULIN N SLIDING SCALE| ASPIRIN - 81MG TWICE A DAY| DESIPRAMINE 50MG 2X A DAY| TIOTROPIUM - 18MG EYE DROPS| METOLOZENE - 2MG 1 PILL| SODIUM - INHALANT 2X A DAY| DOCUSTATE - 100MG 1 PILL/3X A DAY| SIMVASTATIN - 40MG 1/2 TABLET| PREGANONE - 2X A DAY IF NEEDED| REGULAR INSULIN - SLIDING SCALE (SEE COMMENTS).| LACTULOSE - 10MG 2 TABLESPOONS A DAY| VITAMINS - 2 TABS A DAY| FERROUS SULFUR - 1 TABLET A DAY| DIPHENHYDRAMINE 50 MG 1 A DAY| INSULANT - 100MG 40 UNITS A DAY| OMEPRAZOLE - 20MG 1 PILL A DAY| ALBUTEROL - INHALANT 3X A DAY