BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2761013 · Received September 26, 2012

    Report

    Report Number
    1823260-2012-04842
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 31, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM, COMPARED TO A PROFESSIONAL DEVICE, WITHIN 10 MINUTES: 322 MG/DL (ADVANTAGE) AND 108 MG/DL (EMERGENCY ROOM METER). CUSTOMER FELT "FUNNY," WOKE UP SWEATY AND HAD VISION PROBLEMS THAT MORNING. CUSTOMER DROVE TO EMERGENCY ROOM, WHERE THE READINGS WERE TAKEN. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, 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 ROCHE DIAGNOSTICS NA 551680

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR NOVOLIN 70/30| ACTOS| LISINOPRIL| GLYBURIDE