BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 REAGENT PACK

    MDR report key: 2883893 · Received December 21, 2012

    Report

    Report Number
    3007111389-2012-00262
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    September 22, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS DETERMINED THAT REPEATABLE, BUT DISCORDANT VITROS AHIV 1+2 NEGATIVE RESULTS WERE OBTAINED FROM SAMPLES DRAWN FROM A SPECIFIC PATIENT. BASED ON THE PATIENT'S MEDICAL HISTORY AND TESTING USING TWO ALTERNATE NON VITROS ASSAYS, THE VITROS AHIV 1+2 RESULTS ARE CONSIDERED TO BE FALSE NEGATIVE. AN ASSIGNABLE CAUSE HAS NOT BEEN IDENTIFIED. THE INVESTIGATION OF THE EVENT IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED DISCORDANT NEGATIVE VITROS ANTI-HIV 1+2 ((B)(6)) RESULTS FROM TWO SAMPLES COLLECTED FROM ONE SPECIFIC PATIENT (SAMPLE 1: 0.63 AND 0.68 S/C, SAMPLE 2: 0.90 AND 0.83 S/C) USING THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM, WHEN COMPARED TO (B)(6) RESULTS PREDICTED USING TWO NON VITROS ASSAYS. THE VITROS (B)(6) NEGATIVE RESULTS WERE NOT REPORTED FROM THE LABORATORY. HOWEVER, BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF OCCURRED UNDETECTED. THERE WAS NO REPORTED ALLEGATION 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. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 2851

    Patients

    Seq Age Sex Outcome Treatment
    1