BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 922572 · Received October 3, 2007

    Report

    Report Number
    1823260-2007-08625
    Event Type
    Injury
    Date Received
    October 3, 2007
    Date of Event
    September 12, 2007
    Report Date
    October 3, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS BACK TO BACK RESULTS OF 344 MG/DL ON THE INFORM SYSTEM COMPARED TO LAB RESULTS OF 5MG/DL. QUALITY CONTROLS WERE RUN AND IN RANGE. PATIENT WAS BEING TREATED WITH AN INSULIN DRIP BASED ON METER RESULTS. PATIENT WAS TREATED WITH 2.5 AMPS OF D-50 AND AN UNKNOWN AMOUNT OF D-10 AFTER THE LAB RESULTS OF 5MG/DL. PATIENT IS IN ICU IN CRITICAL CONDITION. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A 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 LFR ROCHE DIAGNOSTICS 549643

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention BENEPROTEIN| LOVENOX| DIPRIVAN IV ADJUSTED| ZOSYN| COMBIVENT| REGULAR INSULIN| PROTONIX