BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK

    MDR report key: 4905274 · Received July 10, 2015

    Report

    Report Number
    3007111389-2015-00204
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    November 22, 2014
    Report Date
    July 10, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT UNEXPECTED REPRODUCIBLE POSITIVE VITROS AHBS RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES FROM THE SAME PATIENT WHEN USING TWO DIFFERENT LOTS OF VITROS AHBS REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. ROOT CAUSE FOR THE UNEXPECTED POSITIVE RESULTS COULD NOT BE DETERMINED; HOWEVER, THE POSSIBILITY THAT THE RESULTS ARE SAMPLE RELATED COULD NOT BE RULED OUT. APART FROM THE RESULTS THEMSELVES, THERE WAS NO FURTHER DATA PROVIDED WHICH QUESTIONED THE PERFORMANCE OF THE CUSTOMER'S VITROS AHBS REAGENTS OR VITROS 5600 SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED AFTER OBSERVING UNEXPECTED REPRODUCIBLE POSITIVE VITROS AHBS RESULTS FOR TWO PATIENT SAMPLES FROM THE SAME PATIENT WHEN USING TWO DIFFERENT LOTS OF VITROS AHBS REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. THE TRUE AHBS STATUS OF THE PATIENT SAMPLES WAS DETERMINED TO BE NEGATIVE BASED ON NEGATIVE NON-VITROS AHBS TEST RESULTS AND THE PATIENT'S CLINICAL HISTORY. VITROS AHBS RESULTS: >1000 MIU/ML VS EXPECTED <8 MIU/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE FALSE POSITIVE VITROS AHBS TEST RESULTS WERE REPORTED TO A CLINICIAN HOWEVER NO TREATMENT WAS STARTED, STOPPED OR ALTERED AS A RESULT OF THE EVENTS. THERE WERE NO ALLEGATIONS OF PATIENT HARM MADE. THIS REPORT IS NUMBER ONE OF TWO MDR'S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450480 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK IN-VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS 2620

    Patients

    Seq Age Sex Outcome Treatment
    1