BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS, ANTI-HAV IGM REAGENT

    MDR report key: 2202668 · Received August 11, 2011

    Report

    Report Number
    3007111389-2011-00108
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT UNEXPECTED, NON-REPRODUCIBLE NEGATIVE VITROS ANTI-HAV IGM RESULTS WERE OBTAINED FROM A QUALITY CONTROL SAMPLE PROCESSED ON THE VITROS 3600 SYSTEM. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT OR REAGENT MALFUNCTION OCCURRED. THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED TWO UNEXPECTED, NON-REPRODUCIBLE NEGATIVE VITROS ANTI-HAV IGM RESULTS (B)(6) FROM A (B)(6) ACCURUN CONTROL FLUID PROCESSED ON THE VITROS 3600 SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION SHOULD THEY OCCUR ON PATIENT SAMPLES. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED THEREFORE THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THE INVESTIGATION DETERMINED THE EXPECTED VITROS ANTI-HAV IGM RESULTS FOR THE AFFECTED SAMPLES WERE (B)(6). THIS REPORT IS ONE OF TWO 3500A FORMS BEING SUBMITTED FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (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 2700

    Patients

    Seq Age Sex Outcome Treatment
    1