BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 3080558 · Received April 26, 2013

    Report

    Report Number
    1319681-2013-00093
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED, VITROS PHYT QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 250 CHEMISTRY SYSTEM. AN OCD FE PERFORMED SERVICE ACTIONS TO THE IWF METERING PUMP, AND ACCEPTABLE VITROS PHYT PERFORMANCE WAS OBTAINED AFTER REPLACING THE IWF METERING PUMP. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS CONCLUDED AS INSTRUMENT RELATED. THERE IS NO EVIDENCE TO SUGGEST THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    .THE CUSTOMER OBTAINED HIGHER THAN EXPECTED, VITROS PHYT QUALITY CONTROL RESULTS ON A VITROS 250 CHEMISTRY SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED: QC LOT X1384 = 24.88 VS. AN EXPECTED RESULT = 13.73 UG/ML; QC LOT Y1621 = 45.31, 38.47 VS. AN EXPECTED RESULT = 22.72 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PATIENT RESULTS WERE REPORTED DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183313 VITROS 250 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1