BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 3203024 · Received July 2, 2013

    Report

    Report Number
    1319681-2013-00138
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 27, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT UNEXPECTED, VITROS AMON QUALITY CONTROL RESULTS WERE OBTAINED FROM TWO DIFFERENT NON-VITROS LPV FLUIDS ON A VITROS 5600 SYSTEM. THE ROOT CAUSE OF THE EVENT IS MOST LIKELY ANALYZER RELATED DUE TO INCUBATOR CONTAMINATION. THERE WAS NO EVIDENCE THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED UNEXPECTED, VITROS AMON QUALITY CONTROL RESULTS (130.4, 142.9, 150.9, 148.3, 153.5, 127.4 VS. AN EXPECTED RESULT = 192.7 MMOL/L) FROM TWO DIFFERENT NON-VITROS LPV FLUIDS ON A VITROS 5600 SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED. 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
    301049 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1