BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 687023 · Received March 10, 2006

    Report

    Report Number
    1823260-2006-01155
    Event Type
    Injury
    Date Received
    March 10, 2006
    Date of Event
    February 2, 2006
    Report Date
    March 2, 2006
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED PT WAS ADMITTED UNRESPONSIVE AND GLUCOSE RESULT WAS 188 MG/DL AND ANOTHER TEST MEASURED 180 MG/DL. IT WAS REPORTED 45 MINS LATER A LAB MEASURED 24 MG/DL AND PT WAS TREATED WITH 1 AMP OF D-50 TO ELEVATE GLUCOSE LEVELS. CONTROLS WERE REPORTEDLY RUN AND FOUND TO BE WITHIN RANGE; HOWEVER NO VALUES WERE PROVIDED. 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 BLOOD GLUCOSE MONITORING SYSTEM CFR ROCHE DIAGNOSTICS CORP. NA 548579

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R