BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT

    MDR report key: 2222212 · Received August 24, 2011

    Report

    Report Number
    3007111389-2011-00118
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 24, 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 (B)(6) 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 A NON-SPECIFIC ANTIBODY BLOCKING TUBE YIELDED EXPECTED (B)(6)VITROS ANTI-HAV IGM RESULTS. THE ROOT CAUSE OF THIS EVENT IS THE PRESENCE OF AN INTERFERING SUBSTANCE (NON-SPECIFIC ANTIBODY) WITHIN THE PATIENT SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED REPRODUCIBLE, FALSE (B)(6) VITROS ANTI-HAV IGM RESULTS FROM A SINGLE PATIENT SAMPLE ((B)(6)) WHILE USING THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE PATIENT SAMPLE PRODUCED A (B)(6) RESULT ((B)(6)) FOLLOWING TESTING WITH A NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT) FOR ELIMINATION OF FALSE (B)(6), NON-SPECIFIC ANTIBODY INTERFERENCE FOR ANTI-BODY DETECTION ASSAYS. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED RESULTS WERE NOT REPORTED TO THE CLINICIAN. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. (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 2720

    Patients

    Seq Age Sex Outcome Treatment
    1