BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1133039 · Received August 19, 2008

    Report

    Report Number
    1823260-2008-06311
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    August 9, 2008
    Report Date
    August 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS A BLOOD GLUCOSE RESULT OF 188MG/DL WHILE USING THE ADVANTAGE SYSTEM. CUSTOMER REPORTED A LAB READING 30- 45 MINUTES LATER WITH A RESULT OF 560MG/DL WHILE AT THE DOCTOR AND WAS TREATED IN THE ER WITH A COUPLE OF INSULIN SHOTS AND A BAG AND A HALF OF SALINE SOLUTION. NO QUALITY CONTROLS WERE RUN. 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 550096

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention CHEWABLE ASPIRIN| METOPROLOL TARTRATE| METOPROLOL| LISINOPRIL| "MOOD MEDICINE"| "STOMACH MEDICATION"| HYDROCHLOROTHIAZIDE| NPH| NOVOLIN 70/30| HUMALOG R