BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT

    MDR report key: 2648589 · Received July 10, 2012

    Report

    Report Number
    3007111389-2012-00106
    Event Type
    Malfunction
    Date Received
    July 10, 2012
    Date of Event
    June 8, 2012
    Report Date
    July 10, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. AN OCD FIELD ENGINEER MADE REPAIRS AND ADJUSTMENTS TO THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM, HOWEVER, THERE WAS NO EVIDENCE TO SUGGEST THAT THE SERVICE ACTIONS WERE SPECIFICALLY RELATED TO THE CAUSE OF THIS EVENT. 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 ((B)(6)) FROM A SINGLE PATIENT SAMPLE RUN ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE (B)(6) VITROS ANTI-HAV IGM RESULT WAS QUESTIONED DUE TO A NEGATIVE VITROS ANTI-HAV TOTAL RESULT OBTAINED FROM THE SAME PATIENT SAMPLE. REPEAT ANALYSIS OF THE AFFECTED PATIENT SAMPLE DETERMINED THAT THE EXPECTED RESULT WAS VITROS ANTI-HAV IGM NEGATIVE ((B)(6)). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE FALSE REACTIVE VITROS ANTI-HAV IGM RESULT WAS REPORTED OUT OF THE LABORATORY. 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 3030

    Patients

    Seq Age Sex Outcome Treatment
    1