BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK COMFORT CURVE TEST STRIPS

    MDR report key: 1083646 · Received July 29, 2008

    Report

    Report Number
    1823260-2008-05845
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE VALUE OF 502 MG/DL BACK TO BACK WITH A RESULT OF 58 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. REPORTER STATED THAT AT A DIFFERENT TIME, ANOTHER COMPARATIVE TEST OF 488 MG/DL WAS PERFORMED BACK TO BACK WITH A RESULT OF 53 MG/DL WITH 10 MINUTES ON THE SAME SYSTEM. REPORTER STATED THAT AT A DIFFERENT TIME, ANOTHER COMPARATIVE TEST OF 581 MG/DL WAS PERFORMED BACK TO BACK WITH A RESULT OF 210 MG/DL WITHIN 10 MINUTES ON THE SAME SYSTEM. REPORTER STATED THAT THE CUSTOMER SELF-TREATED WITH ORANGE JUICE AND TOAST WITH THE FIRST TWO INCIDENTS. NO OTHER ACTIONS WERE REPORTEDLY 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-CHECK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550634

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR LISINOPRIL - 40MG TWICE DAILY| NOVOLOG - 20 UNITS 3 TIMES DAILY| LANTUS - 40 UNITS DAILY