BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 5235427 · Received November 19, 2015

    Report

    Report Number
    1319681-2015-00148
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Date of Event
    October 21, 2015
    Report Date
    November 19, 2015
    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 THE VITROS 5600 INTEGRATED SYSTEM DID NOT MALFUNCTION AND OPERATED AS DESIGNED. HOWEVER, IT WAS NOT CONFIGURED TO PREDICT AND REPORT TT3 VALUES IN THE INTENDED MEASURING UNIT DUE TO OPERATOR ERROR. THE INVESTIGATION CANNOT CONCLUDE THERE WOULD NOT BE POTENTIAL FOR PATIENT HARM IF THE SAME USER ERROR WERE TO RECUR IN THE FUTURE UNDETECTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS TECHNICAL SOLUTIONS CENTER ( ORTHO TSC) TO REPORT THAT THE LABORATORY INFORMATION SYSTEM (LIS) REPORTED DISCORDANT PLASMA TT3 RESULTS WHEN COMPARED TO THE VITROS 5600 INTEGRATED SYSTEM LABORATORY REPORT. AS A RESULT, 13 SAMPLES UNEXPECTEDLY WERE REPORTED OUT AS <7 NG/ML ON THE CUSTOMER&#38112;LIS. CORRECTED REPORTS WERE ISSUED AND THERE WERE NO REPORTS OF TREATMENT ALTERED, INITIATED OR STOPPED BASED ON THE REPORTED RESULTS. THERE WAS NO ALLEGATION 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
    765060 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1