BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 3232599 · Received July 18, 2013

    Report

    Report Number
    1319681-2013-00141
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, VITROS AMON QUALITY CONTROL RESULT WAS OBTAINED FROM A BIORAD LEVEL 2 FLUID ON A VITROS 5600 SYSTEM. AN OCD FIELD ENGINEER PERFORMED ROUTINE SERVICE ACTIONS ON THE MICROSLIDE INCUBATOR SUBSYSTEM OF THE ANALYZER. FOLLOWING THESE SERVICE ACTIONS, ACCEPTABLE VITROS AMON PERFORMANCE WAS OBSERVED USING THE SAME REAGENT LOT. 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.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON- REPRODUCIBLE, VITROS AMON QUALITY CONTROL RESULT (97.5 VS. AN EXPECTED RESULT = 79.0 MOL/L) FROM A BIORAD LEVEL 2 FLUID 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. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334591 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1