BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1513161 · Received October 13, 2009

    Report

    Report Number
    1823260-2009-07071
    Event Type
    Malfunction
    Date Received
    October 13, 2009
    Date of Event
    October 3, 2009
    Report Date
    October 13, 2009
    Manufacturer
    OCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B) (4) FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 573 MG/DL ON ADVANTAGE SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 136 MG/DL ON ADVANTAGE SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT SHE TOOK TWO GLYBURIDE TABS, AS NORMAL, IN BETWEEN OBTAINING THE TWO RESULTS. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOG GLUCOSE MONITORING TEST STRIPS - LFR LFR OCHE DIAGNOSTICS 550939

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR DIOVAN| "CHEPRAZOLE"| SIMVASTATIN| GLYBURIDE| FUROSEMIDE| KLOR-CON| GABAPENTIN