BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT

    MDR report key: 2150706 · Received July 6, 2011

    Report

    Report Number
    3007111389-2011-00088
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 8, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, FALSE POSITIVE ANTI-HAV IGM RESULTS OCCURRED WHILE USING MULTIPLE VITROS ECIQ ANALYZERS. A ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. HOWEVER, THE PATIENT SAMPLES INVOLVED OR AN UNKNOWN SAMPLE INTERFERENT CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. PERFORMANCE TESTING DEMONSTRATED THAT THE AFFECTED VITROS ECIQ ANALYZERS WERE OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED (B)(6) VITROS ANTI-HAV IGM RESULTS FROM MULTIPLE PATIENT SAMPLES (PATIENTS 1, 2, AND 3 = (B)(6) RESULT VS. (B)(6) RESULT FROM VITROS ANTI-HAV TOTAL) WHILE USING MULTIPLE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEMS. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULTS WERE NOT REPORTED TO THE CLINICIAN. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDR'S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT IN-VITRO-DIAGNOSTIC LOL ORTHO-CLINICAL DIAGNOSTICS 2650

    Patients

    Seq Age Sex Outcome Treatment
    1