BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT

    MDR report key: 3004816 · Received March 14, 2013

    Report

    Report Number
    3007111389-2013-00064
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS HCG RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHILE USING THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN. HOWEVER, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT OR A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS HCG RESULT (10.95 VS. EXPECTED RESULT <2.39 MIU/ML) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT SAMPLE WAS REPEATED PRIOR TO REPORTING AS THE RESULT WAS UNEXPECTED. 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
    108120 VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT IN-VITRO DIAGNOSTIC DHA ORTHO-CLINICAL DIAGNOSTICS 0790

    Patients

    Seq Age Sex Outcome Treatment
    1