BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELAN ATAC 8000

    MDR report key: 305659 · Received November 20, 2000

    Report

    Report Number
    MW1020457
    Event Type
    Malfunction
    Date Received
    November 20, 2000
    Date of Event
    February 1, 2000
    Report Date
    November 20, 2000
    Manufacturer
    ELAN DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SINCE INSTRUMENT WAS INSTALLED 9 MOS AGO, HOSP HAS DETERMINED THAT INSTRUMENT HAS POOR PRECISION, POOR REPRODUCIBILITY REAGENTS DID NOT LAST AS LONG AS STATED IN MFR'S MANUAL, INSTRUMENT PRESENTED IN DECEPTIVE MANNER, PROFICIENCY TESTING SHOWS POOR COEFFICIENT OF VARIATION AND STANDARD DEVIATION, POOR FOR CPK, LDH, AST, ALT AND ALKALINE PHOSPHATASE. SYSTEM HAS LOCKUPS THAT OCCUR WITH FREQUENCY AND USER CAN SPEND UP TO 15 MINUTES TRYING TO GET OUT OF LOCKUPS. SOMETIMES HAVING TO TURN MACHINE OFF AND LOSING TESTING. WAS TOLD THAT INSTRUMENT WOULD TAKE 15 MINUTES TO GET UP AND RUNNING IN THE MORNING BUT ACTUALLY TAKES AN HOUR. HOSP HAS NEVER BROUGHT PT ONLINE FOR PT TESTING. MFR HAS BEEN CONTACTED MANY TIMES CONCERNING THESE PROBLEMS. MFR MAINTAINS THAT INSTRUMENT HAS BEEN WORKING ADEQUATELY. REPORTER ALSO IS AWARE OF OTHER PROBLEMS WITH THIS DEVICE IN THEIR STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELAN ATAC 8000 CHEMISTRY ANALYZER JJE ELAN DIAGNOSTICS 8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA