BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2883694 · Received December 21, 2012

    Report

    Report Number
    1319681-2012-00257
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT AN UNEXPECTED DELAY IN OBTAINING INTRA-OPERATIVE VITROS IPTH RESULT WAS OBSERVED FOR SINGLE PATIENT SAMPLE ON TWO DIFFERENT VITROS 5600 SYSTEMS. THE INVESTIGATION DETERMINED THAT THE DELAY WAS CAUSED DUE TO TEMPORARY MECHANICAL ISSUES ON BOTH VITROS 5600 SYSTEMS. BOTH ISSUES WERE TEMPORARY AND WERE RESOLVED BY ROUTINE OPERATOR ACTIONS ALLOWING THE SAMPLE TO BE PROCESSED SUCCESSFULLY. HOWEVER, THERE WAS NO MALFUNCTION OF THE VITROS 5600 SYSTEM OR VITROS IPTH REAGENT IDENTIFIED. THE ROOT CAUSE OF THIS EVENT IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED AN UNEXPECTED DELAY IN OBTAINING INTRA-OPERATIVE VITROS IPTH RESULT FOR A SINGLE PATIENT SAMPLE ON TWO DIFFERENT VITROS 5600 SYSTEMS. A DELAY OF APPROXIMATELY ONE HOUR WAS OBSERVED WITH RESPECT TO THE EXPECTED TURNAROUND TIME. DUE TO THIS DELAY IN OBTAINING VITROS IPTH RESULTS, THE PATIENT WAS HELD UNDER ANESTHESIA FOR AN ADDITIONAL 30 MINUTES WHILE UNDERGOING A SURGICAL PROCEDURE. THE LIKELIHOOD OF AN INCREMENTAL INCREASE IN THE INHERENT HEALTH RISKS TO THE PATIENT DUE TO EXTENDED TIME UNDER ANESTHESIA IS NOT REMOTE. ONCE THE VITROS IPTH RESULTS WERE OBTAINED, THE SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF HARM TO THE PATIENT AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR'S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1