BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 3000084 · Received March 12, 2013

    Report

    Report Number
    1319681-2013-00062
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    December 31, 2012
    Report Date
    March 12, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NONREPRODUCIBLE VITROS AMON QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 250 CHEMISTRY SYSTEM. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO RETURN THE VITROS 250 INSTRUMENT TO ACCEPTABLE PERFORMANCE. THE ROOT CAUSE OF THIS EVENT IS MOST LIKELY INSTRUMENT RELATED. THERE WAS NO EVIDENCE THAT A REAGENT ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NONREPRODUCIBLE VITROS AMON QUALITY CONTROL RESULTS ON A VITROS 250 CHEMISTRY SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED FOR VITROS AMON USING VITROS LPV: QC LOT B1408 = 135, 154, 153, 144, 147, 148, 150, 154, 139, 152, 152, 151 VS. AN EXPECTED RESULT = 195.5 MMOL/L; BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NO VITROS AMON PATIENT RESULTS WERE QUESTIONED. 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
    102859 VITROS 250 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1