BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 855717 · Received May 24, 2007

    Report

    Report Number
    1823260-2007-04486
    Event Type
    Malfunction
    Date Received
    May 24, 2007
    Date of Event
    May 7, 2007
    Report Date
    May 24, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED DISCREPANT BLOOD GLUCOSE RESULTS OF 287 MG/DL BACK TO BACK WITH A RESULT OF 121 MG/DL WHEN TESTING WAS PERFORMED A FEW MINUTES APART ON THE ADVANTAGE SYSTEM. NO REPORT OF ACTIONS TAKEN OR TREATMENT RECEIVED. 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 549616

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR METOCLOPRAMIDE 6YRS - 10MG ONCE DAILY| TRICOR 5YRS - 145MG ONCE DAILY| PROTONIX 6YRS - 40MG ONCE DAILY| HCTZ >3YRS - 12.5 MG 1/2 TABLET ONCE DAILY| ALLEGRA D 10-15YRS - 120MG TWICE DAILY| GLUCOPHAGE 2 YRS - 500MG ONCE DAILY| ZETIA 5YRS - 10MG ONCE DAILY| ACTONEL 3YRS - 35MG ONCE DAILY| CALTRATE 3WKS - 600MG ONCE DAILY| AGGRENOX 3 YRS - 200MG TWICE DAILY