BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI HAV IGM REAGENT

    MDR report key: 2402779 · Received January 6, 2012

    Report

    Report Number
    3007111389-2012-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    December 9, 2011
    Report Date
    January 6, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT (B)(6) VITROS ANTI-HAV IGM RESULTS WERE OBTAINED FROM SAMPLES COLLECTED FROM THREE DIFFERENT PATIENTS, PROCESSED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE ASSIGNABLE CAUSE FOR THE EVENT COULD NOT BE DETERMINED, HOWEVER, AN UNKNOWN SAMPLE INTERFERENT CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. ANALYSIS OF 3600 SYSTEM DATA LOGS AND VITROS ANTI-HAV IGM QUALITY CONTROL PERFORMANCE FOUND NO INDICATION THAT THE VITROS 3600 SYSTEM MALFUNCTIONED. ANALYSIS OF CUSTOMER COMPLAINTS AGAINST THE VITROS ANTI-HAV IGM ASSAY FOUND ADDITIONAL RELATED COMPLAINTS HAD BEEN RECEIVED ACROSS MULTIPLE REAGENT KIT LOTS, AND THIS ISSUE IS BEING INTERNALLY INVESTIGATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DISCORDANT, (B)(6) VITROS (B)(6) RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES USING TWO DIFFERENT LOT NUMBERS OF VITROS ANTI HAV IGM REAGENT ON A VITROS 3600 SYSTEM, COMPARED TO NEGATIVE VITROS ANTI HAV TOTAL RESULTS. PATIENT 1 (B)(6) RESULT = (B)(6) (LOT 2920), PATIENT 2 RESULTS WERE (B)(6) (LOT 2830), (B)(6)(LOT 2920), AND PATIENT 3 RESULTS WERE(B)(6) (BOTH LOT 2920) COMPARED TO (B)(6) TOTAL NEGATIVE RESULTS (SPECIFIC RESULTS NOT PROVIDED). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULTS FOR PATIENTS 1 AND 3 WERE NOT REPORTED OUTSIDE OF THE LABORATORY; HOWEVER, IT IS UNKNOWN IF THE AFFECTED PATIENT RESULT FOR PATIENT 2 WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER 1292783/ IVD 229517 THIS REPORT IS NUMBER THREE OF FOUR 3500A FORMS FILED FOR THIS EVENT, AS THE ROOT CAUSE OF THE EVENT IS AN UNKNOWN INTERFERENT IN 3 PATIENT SAMPLES, WITH 2 LOTS OF REAGENT INVOLVED.

    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 2920

    Patients

    Seq Age Sex Outcome Treatment
    1