BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2150641 · Received July 6, 2011

    Report

    Report Number
    1319681-2011-00143
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 11, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULT WAS OBTAINED FOR A SINGLE PATIENT. AN OCD FIELD ENGINEER PERFORMED "AS NEEDED" SERVICE TO THE WELL WASH AND MICROWELL INCUBATOR SUBSYSTEMS TO REPLACE DAMAGED AND WORN PARTS AND TO OPTIMIZE ANALYZER ADJUSTMENTS. PERFORMANCE TESTING FOLLOWING SERVICE VERIFIED THAT THE EQUIPMENT WAS OPERATING AS EXPECTED. THE MOST LIKELY, ASSIGNABLE CAUSE FOR THIS EVENT IS AN EQUIPMENT RELATED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULT (1.16 NG/ML) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED TROP I ES PATIENT RESULT WAS REPORTED TO THE CLINICIAN THEN REPEATED (0.017 NG/ML), BUT NOT BEFORE ADDITIONAL ACTIONS WERE TAKEN FOR THE PATIENT. 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
    1 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1