BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT

    MDR report key: 2944371 · Received February 5, 2013

    Report

    Report Number
    3007111389-2013-00030
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 4, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS HCG RESULTS WERE OBTAINED FROM THREE DIFFERENT PATIENT SAMPLES WHILE USING THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED AND/OR A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS HCG RESULTS (PATIENT 1 = 10.88, PATIENT 2 = 14.45, PATIENT 3 = 150 VS. EXPECTED RESULTS < 2.39 MIU/ML) FROM THREE DIFFERENT PATIENT SAMPLES PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE AFFECTED RESULTS WERE IDENTIFIED DUE TO PATIENT HISTORY AND REPEATED PRIOR TO REPORTING. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE 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
    48429 VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT IN-VITRO DIAGNOSTIC DHA ORTHO-CLINICAL DIAGNOSTICS 0750

    Patients

    Seq Age Sex Outcome Treatment
    1