BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2991666 · Received March 6, 2013

    Report

    Report Number
    1319681-2013-00059
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROP I ES RESULTS WERE OBTAINED FROM TWO DIFFERENT SAMPLES OBTAINED FROM A SINGLE PATIENT PROCESSED ON THE VITROS 5600 SYSTEM. SERVICE REPAIR ACTIONS WERE PERFORMED TO RETURN THE SYSTEM TO NOMINAL OPERATION. ADDITIONALLY, THE SAMPLE MAY NOT HAVE BEEN PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE MOST LIKELY ASSIGNABLE CAUSE IS AN INSTRUMENT RELATED ISSUE. ADDITIONALLY, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE WAS NO EVIDENCE THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROP I ES RESULTS (SAMPLE 1 = 0.070, SAMPLE 2 = 0.063, 0.064 VS. EXPECTED RESULT = 0.028 NG/ML) FROM TWO DIFFERENT SAMPLES OBTAINED FROM A SINGLE PATIENT PROCESSED ON THE VITROS 5600 SYSTEM. THE AFFECTED PATIENT RESULT OF 0.063 NG/ML WAS REPORTED OUT OF THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER REPEATED THE AFFECTED SAMPLES AS THE PHYSICIAN QUESTIONED THE RESULT. A CORRECTED RESULT WAS ISSUED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95947 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1