BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT

    MDR report key: 3023903 · Received March 27, 2013

    Report

    Report Number
    2521625-2013-00001
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS PSA QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. ACCEPTABLE PSA QUALITY CONTROL RESULTS WERE OBTAINED FROM AN ALTERNATE PSA REAGENT PACK OF THE SAME LOT. ROOT CAUSE OF THE LOWER THAN EXPECTED QUALITY CONTROL RESULTS COULD NOT BE DETERMINED. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS PSA QUALITY CONTROL RESULTS (LEVEL 1 = 1.77 VS. AN EXPECTED RESULT = 2.4; LEVEL 2 = 15.7 VS. AN EXPECTED RESULT = 21 NG/ML) WHILE USING QC LOT 27908 PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED. 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
    125719 VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT IN-VITRO DIAGNOSTIC LTJ ORTHO-CLINICAL DIAGNOSTICS 2930

    Patients

    Seq Age Sex Outcome Treatment
    1