BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1897006 · Received November 11, 2010

    Report

    Report Number
    1823260-2010-06704
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    November 6, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 321 MG/DL ON THE AVIVA SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 121 MG/DL ON THE PROFESSIONAL SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 551134

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR GLYBURIDE| METFORMIN