BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 7320432 · Received March 7, 2018

    Report

    Report Number
    1319681-2018-00025
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 11, 2018
    Report Date
    March 7, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS PHYT RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER QUALITY CONTROL SAMPLE USING A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THIS EVENT WAS INSTRUMENT RELATED. THE IMMUNO-WASH FLUID (IWF) TIP WAS BENT, AND THE IWF RESERVOIR COVER WAS NOT IN POSITION. IT IS LIKELY THE IWF TIP HIT THE ¿OUT OF POSITION¿ RESERVOIR COVER, CAUSING THE TIP TO BEND, WHICH IN RETURN DELIVERED AN INSUFFICIENT VOLUME OF IWF. ACCEPTABLE VITROS PHYT PERFORMANCE WAS OBTAINED AFTER REPLACING THE IWF TIP AND FLUID. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY ASSIGNABLE CAUSE OF THIS EVENT WAS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED HIGHER THAN EXPECTED PHYT QUALITY CONTROL RESULTS USING A VITROS 5600 INTEGRATED SYSTEM (UNITS ARE ¿G/ML): TDM PV L3 LOT T5896 VITROS PHYT RESULTS OF >0.40 (X4) ¿G/ML VERSUS EXPECTED VALUE OF 28.1 ¿G/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED AND NO ALLEGATION OF PATIENT HARM AS A CAUSE OF THIS EVENT. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165573 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1