BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1801590 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04841
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 23, 2010
    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 WITHIN 10 MINUTES: 513 MG/DL AND 115 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD ALL THREE (CHARGE PAK, ATTENTION AND WRENCH) ICONS ILLUMINATED AND IT FAILED TO POWER ON WHEN THE CUSTOMER RETRIEVED IT FROM STORAGE TO DEPLOY TO SERVICE. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

    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 551080

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR BABY ASPIRIN| CENTRUM SILVER| WHEEL CHAIR| GLYBURIDE| METFORMIN