BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1122852 · Received August 14, 2008

    Report

    Report Number
    1823260-2008-06216
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 490 MG/DL BACK TO BACK WITH A RESULT OF 121 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINS. REPORTER INDICATED THAT HE WAS NOT EXPERIENCING ANY HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. 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 550678

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR SIMISINEMET - 100MG ONCE| SOTALOL - 20 YRS - "160MG TWICE"| ISOSORBIDE - 20 YRS "20MG TWICE"| ATENOLOL - 20 YRS "25MG ONCE"| ROSIGLITAZONE MALEATE - 20 YRS - 2MG ONCE| LANTUS - 3 YRS - 12 UNITS NIGHTLY| LISINOPRIL - 20 YRS - 5MG ONCE| ASPIRIN - 20 YRS "80MG TWICE"| SERTRALINE - 20 YRS - 50MG ONCE| SIMVASTATIN - 20 YRS - 5MG ONCE| APIDRA - 1 YR - 12 UNITS DAILY| COUMADIN - 20 YRS - 5MG TWICE WEEKLY| TAMSULOSIN - 20 YRS - 0.4MG ONCE| METFORMIN - 20 YRS - 500MG ONCE