BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 700 COMPLETE WITH ISE

    MDR report key: 1770723 · Received October 29, 2007

    Report

    Report Number
    1823260-2007-09391
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    October 17, 2006
    Report Date
    October 29, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER NOTICING "CUP EMPTY" AND "INSUFFICIENT VOLUME" ERRORS ON THEIR ANALYZER, THE ACCOUNT NOTICED THEY HAD REPORTED AN INCORRECT BUN RESULT FOR A PATIENT. THE INITIAL BUN RESULT WAS 18 MG/DL AND WHEN A SECOND SAMPLE WAS MEASURED FOR BUN, THE RESULT WAS 103 MG/DL. THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 106 MG/DL. NO ADVERSE EVENTS WERE REPORTED IN ASSOCIATION WITH THE INCORRECT RESULT. IT WAS DETERMINED THAT THE ST1 PROBE WAS DAMAGED AND THE INSTRUMENT WAS REPAIRED BY THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 700 COMPLETE WITH ISE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR CUSTOMER DOES NOT KNOW.