BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT

    MDR report key: 2463905 · Received February 22, 2012

    Report

    Report Number
    3007111389-2012-00019
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 20, 2012
    Report Date
    February 22, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE FALSE REACTIVE VITROS ANTI-HAV IGM RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE RUN ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT OR REAGENT MALFUNCTION OCCURRED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. THERE WAS NO EVIDENCE TO SUGGEST PRE-ANALYTICAL ERROR INVOLVING SAMPLE MIX-UP OCCURRED, HOWEVER IT COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE FALSE REACTIVE VITROS ANTI-HAV IGM RESULT (1.88 S/C) FROM A SINGLE PATIENT SAMPLE RUN ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. REPEAT ANALYSIS OF THE SAME SAMPLE DETERMINED THAT THE EXPECTED RESULT WAS VITROS ANTI-HAV IGM NEGATIVE (0.42 S/C). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE FALSE REACTIVE VITROS ANTI-HAV IGM RESULT WAS INITIALLY RELEASED OUT OF THE LABORATORY, HOWEVER A CORRECTED REPORT WAS ISSUED. THERE WAS NO REPORT OF PATIENT HARM 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 2880

    Patients

    Seq Age Sex Outcome Treatment
    1