BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 ANALYZER

    MDR report key: 900586 · Received October 14, 2004

    Report

    Report Number
    1319681-2004-00268
    Event Type
    Malfunction
    Date Received
    October 14, 2004
    Date of Event
    September 13, 2004
    Report Date
    September 22, 2004
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE BIASED QC RESULTS WERE CAUSED BY A LACK OF PRESSURIZATION IN THE IWF METERING PUMP. OCD FIELD SERVICE WAS SENT TO THE CUSTOMER SITE AND REPLACED THE IWF PUMP AND ADJUSTED THE IR METERING POSITION, THE CUSTOMER PERFORMED A NEW CALIBRATION AND DID NOT OBSERVE ANY ADDITIONAL BIASED QC RESULTS. THIS EVENT WAS CAUSED BY A MLAFUNCTIONING IWF PUMP.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBSERVING BIASED QC RESULTS FOR PHYT. THIS EVENT IS CONSISTENT WITH A MALFUNCTION THAT MAY RESULT IN INAPPROPRIATE PHYSICIAN ACTION. RESULTS WERE NOT REPORTED AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 250 ANALYZER CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA