BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1060057 · Received June 12, 2008

    Report

    Report Number
    1823260-2008-04677
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 17, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE VALUE OF 543 MG/DL BACK TO BACK WITH A RESULT OF 102 MG/DL, WHEN TESTING WAS PERFORMED WITHIN 10 MINS ON THE ADVANTAGE SYSTEM. REPORTER STATED THAT AT A DIFFERENT TIME ANOTHER COMPARATIVE TEST OF 336 MG/DL WAS PERFORMED BACK TO BACK WITH A RESULT OF 70 MG/DL WITHIN 10 MINS ON THE SAME SYSTEM. NO 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 550042

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR PREDNISONE: 2 6 YEARS| VYTORIN: 2YEARS -10-20MG DAILY| BENICAR: 5 YEARS-40-25MG DAILY| AVANDIA: 6YEARS| VITAMIN AND IRON: 5-6 YEARS- 1TAB DAILY| CALCIUM: 3-4 YEARS- 1200MG DAILY| MICRONASE: 6 YEARS| "CONJORTIN": 1YEAR-1200MG 2 TABS DAILY| GLUCOSAMINE: 1YEAR-1500MG TWICE DAILY