BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1062372 · Received June 18, 2008

    Report

    Report Number
    1823260-2008-04826
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 269 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 69 MG/DL ON THE DOCTOR'S SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART AND HER STRIPS WERE STORED OUTSIDE OF THE VIAL. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR ACTOPLUS - 850MG TWICE DAILY| LANTUS - 22 UNITS/DAILY