BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 639163 · Received October 1, 2005

    Report

    Report Number
    1823260-2005-02936
    Event Type
    Injury
    Date Received
    October 1, 2005
    Date of Event
    August 26, 2005
    Report Date
    September 1, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED DUE TO BLOOD GLUCOSE MONITORING DEVICE RESULTS, BEING ADMITTED TO THE HOSP AND TREATED OVER A WEEKEND. REPORTER STATED GLUCOSE RESULTS PRIOR TO THE ALLEGED INCIDENT WERE 133, 124, 331, & 171 MG/DL HOWEVER NO TIME AND DATE INFO WAS AVAILABLE FOR THEM. REPORTER STATED FEELING WEAK THE DAY OF THE ALLEGED INCIDENT AND WAS TRANSPORTED TO THE HOSP BY AMBULANCE SHORTLY AFTER 10:00 PM. REPORTER STATED HOSP GLUCOSE DEVICE RESULT WAS 360 MG/DL. REPORTER INDICATED BEING TREATED AT THE HOSP WITH GLUCOSE AND FLUIDS. REPORTER STATED NO CONTROLS WERE USED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT PRODUCT 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 LFR ROCHE DIAGNOSTICS NA 548510

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R