BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HAV IGM REAGENT

    MDR report key: 2132129 · Received June 17, 2011

    Report

    Report Number
    3007111389-2011-00082
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 17, 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 A FALSE REACTIVE VITROS ANTI-HAV IGM RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT OR REAGENT MALFUNCTION OCCURRED. TREATING THE AFFECTED PATIENT SAMPLE USING NON-SPECIFIC ANTIBODY AND HETEROPHILIC ANTIBODY BLOCKING TUBES YIELDED NEGATIVE VITROS ANTI-HAV IGM RESULTS. THE ROOT CAUSE OF THIS EVENT IS THE PRESENCE OF AN INTERFERING SUBSTANCE (NON-SPECIFIC ANTIBODY AND/OR HETEROPHILIC ANTIBODY) WITHIN THE PATIENT SAMPLE. THE VITROS ANTI-HAV IGM INSTRUCTIONS FOR USE STATE, "HETEROPHILIC ANTIBODIES IN THE SERUM OR PLASMA SAMPLES CAN CAUSE INTERFERENCE WITH IMMUNOASSAYS. HETEROPHILIC ANTIBODIES MIGHT BE PRESENT IN BLOOD SAMPLES FROM INDIVIDUALS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR WITH ANIMAL PROTEINS DURING IMMUNOTHERAPY."

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A FALSE REACTIVE VITROS ANTI-HAV IGM RESULT (1.67 S/C) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE FALSE REACTIVE VITROS IGM RESULT WAS RELEASED OUT OF THE LABORATORY, HOWEVER THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THE INVESTIGATION DETERMINED THE EXPECTED (B)(6) RESULT FOR THE AFFECTED PATIENT SAMPLE WAS NEGATIVE (B)(6). THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1