BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK

    MDR report key: 8621432 · Received May 17, 2019

    Report

    Report Number
    3007111389-2019-00087
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 23, 2019
    Report Date
    May 17, 2019
    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 A DISCORDANT, REACTIVE VITROS ANTI-HBC IGM (AHBCM) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM, WHEN COMPARED TO A NON-REACTIVE RESULT OBTAINED WHEN USING A NON-VITROS (ROCHE) METHOD. A DEFINITIVE ASSIGNABLE CAUSE FOR THE DISCORDANT REACTIVE RESULT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE ACCEPTABLE HISTORICAL VITROS AHBCM QUALITY CONTROL RESULTS, A REAGENT ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. PRECISION TESTING OF THE VITROS 5600 INTEGRATED SYSTEM WAS NOT PERFORMED, THEREFORE IT CANNOT BE CONFIRMED THAT THE INSTRUMENT WAS OPERATING AS INTENDED AND UNEXPECTED INSTRUMENT PERFORMANCE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. ADDITIONALLY, THE PRESENCE OF AN UNKNOWN SAMPLE INTERFERENT CANNOT BE COMPLETELY RULED OUT AS THE CAUSE OF THE DISCORDANT REACTIVE RESULT AS TESTING USING A HBT (HETEROPHILIC BLOCKING TUBE) WAS NOT COMPLETED FOR THE AFFECTED SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A DISCORDANT, REACTIVE VITROS ANTI-HBC IGM (AHBCM) RESULT FROM A SINGLE PATIENT SAMPLE WHEN PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM, WHEN COMPARED TO A NON-REACTIVE RESULT OBTAINED WHEN USING A NON-VITROS (ROCHE) METHOD. VITROS AHBCM RESULT 3.47 S/C (REACTIVE) VERSUS NON-VITROS (ROCHE) NON-REACTIVE AHBCM RESULT BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE DISCORDANT REACTIVE VITROS AHBCM RESULT WAS NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415347 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK IN-VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS 1750

    Patients

    Seq Age Sex Outcome Treatment
    1