BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771223 · Received February 18, 2008

    Report

    Report Number
    1823260-2008-01645
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED DISCREPANT BLOOD GLUCOSE VALUES OF 383 MG/DL BACK-TO-BACK WITH A RESULT OF 172 MG/DL WHEN TESTING WAS PERFORMED WITHIN ONE MINUTE OF EACH OTHER ON THE ADVANTAGE SYSTEM. REPORTER STATED THE CUSTOMER WAS NOT EXPERIENCING ANY HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF THE TESTING. NO ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT WAS RECEIVED BY THE CUSTOMER. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 LFR ROCHE DIAGNOSTICS 550022

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR GLYBURIDE - 5 YRS, 6MG TWICE DAILY| TYLENOL - 5 YRS, 500MG AS NEEDED| PROTONIX - 3 YRS, 40MG ONCE DAILY| HUMALOG - 2 MOS, SLIDING SCALE| ASPIRIN - 5 YRS 81NG, ONCE DAILY| TRAMADOL - 5 YRS, 50MG AS NEEDED| ACTOS - 8 MOS, 30MG ONCE DAILY