BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT

    MDR report key: 2832363 · Received November 14, 2012

    Report

    Report Number
    3007111389-2012-00227
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE (B)(6) VITROS ANTI-HAV IGM RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES RUN ON THE VITROS ECI SYSTEM. THERE IS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT RELATED ISSUE AND/OR A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN. HOWEVER, POOR SAMPLE PROCESSING, POOR SAMPLE HANDLING OR A SAMPLE MIX-UP ISSUE COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS. THE OCCUPATION OF THE INITIAL REPORTER IS NOT KNOWN AT THE TIME OF FILING OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE (B)(6) VITROS ANTI-HAV IGM RESULTS ((B)(6)) FROM TWO DIFFERENT PATIENT SAMPLES RUN ON THE VITROS ECI SYSTEM. THE LABORATORY QUESTIONED THE (B)(6) RESULTS DUE TO (B)(6) RESULTS BEING OBTAINED FROM THE RESPECTIVE PATIENTS. REPEAT ANALYSIS OF THE AFFECTED PATIENT SAMPLES DETERMINED THAT THE EXPECTED RESULTS WERE VITROS ANTI-HAV IGM (B)(6). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE (B)(6) VITROS ANTI-HAV IGM RESULTS WERE NOT 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 3080

    Patients

    Seq Age Sex Outcome Treatment
    1