BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCT HBSAG REAGENT

    MDR report key: 3370357 · Received September 26, 2013

    Report

    Report Number
    3007111389-2013-00189
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Date of Event
    August 27, 2013
    Report Date
    September 26, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT, (B)(6) RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHILE USING THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. AN UNKNOWN SAMPLE INTERFERENT COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. FURTHER INVESTIGATION IS ONGOING TO DETERMINE IF AN INSTRUMENT OR REAGENT RELATED EVENT CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED DISCORDANT, VITROS (B)(6) RESULTS FROM 5 DIFFERENT PATIENT SAMPLES ON TWO DIFFERENT VITROS 3600 IMMUNODIAGNOSTIC SYSTEMS THAT WERE (B)(6) WHEN TESTED ON 2 DIFFERENT NON-VITROS METHODS. PATIENT 1: (B)(6) RESULTS FROM 2 DIFFERENT NON-VITROS METHODS. PATIENT 2: (B)(6). RESULTS FROM 2 DIFFERENT NON-VITROS METHODS. PATIENT 3: (B)(6). RESULTS FROM 2 DIFFERENT NON-VITROS METHODS. PATIENT 4:(B)(6). RESULTS FROM 2 DIFFERENT NON-VITROS METHODS. PATIENT 5: (B)(6). RESULTS FROM 2 DIFFERENT NON-VITROS METHODS. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NONE OF THE 5 DISCORDANT, NEGATIVE (B)(6) RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO 3500A FORMS FILED FOR THIS EVENT, AS TWO DEVICES WERE AFFECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488500 VITROS IMMUNODIAGNOSTICS PRODUCT HBSAG REAGENT IN VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS 7420

    Patients

    Seq Age Sex Outcome Treatment
    1