BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1181941 · Received September 22, 2008

    Report

    Report Number
    1823260-2008-07068
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF HI (GREATER THAN 600 MG/DL) AND HI ON A PATIENT USING THE INFORM SYSTEM COMPARED TO BACK TO BACK WITH A RESULT OF 162 MG/DL ON THE LAB 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 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 CORP. 550605

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR COREG - 6.25MG DAILY| PROZAC - 20MG DAILY| NAMENDA - 10MG TWICE DAILY| ZOCOR - 20MG DAILY| PRANDIN - 0.5MG 3 TIMES DAILY| ASA - 81MG DAILY| REGULAR INSULIN - SLIDING SCALE| EXELON - 3MG TWICE DAILY| LANTUS - 30 UNITS DAILY| DEPAKOTE - 125MG 3 TIMES DAILY| RISPERDAL - 0.25MG 3 TIMES DAILY