BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1841656 · Received September 22, 2010

    Report

    Report Number
    1823260-2010-05629
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    July 17, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN ADVANTAGE METER, COMPARED TO A PROFESSIONAL METER, WITHIN 10 MINUTES: HI (GREATER THAN 600 MG/DL) (ADVANTAGE) AND 60S-RANGE MG/DL (HOSPITAL'S METER) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. CUSTOMER WAS FEELING DIZZY AND DROVE TO THE EMERGENCY ROOM, WHERE SHE WAS TESTED AT 60S-RANGE MG/DL ON THE ER METER. CUSTOMER WAS TOLD SHE HAD LOW BLOOD GLUCOSE AND WAS RELEASED WITHOUT TREATMENT. CUSTOMER WENT HOME TO SELF-TREAT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, CUSTOMER NO LONGER HAS TEST STRIPS. 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 ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR METFORMIN| "HIGH BLOOD PRESSURE"