BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO REAGENT PACK

    MDR report key: 18483490 · Received January 10, 2024

    Report

    Report Number
    3007111389-2024-00004
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 12, 2023
    Report Date
    January 9, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    MZF
    UDI-DI
    10758750031580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT DISCORDANT NON-REACTIVE VITROS HIV COMBO RESULTS WERE OBTAINED FROM A REACTIVE VITROS HIV P24 ANTIGEN QC FLUID LOT 0150 WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCTS HIV COMBO (HIVC) REAGENT LOT 0950 IN CONJUNCTION WITH A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE CANNOT BE DETERMINED. THE CUSTOMER MADE NO SUGGESTION OF ANY ISSUES WITH THE OTHER QC FLUIDS PROCESSED AT THE CUSTOMER SITE AND NO ISSUES REGARDING ACCURACY OR PRECISION OF THE VITROS ASSAY WERE INDICATED BY THE CUSTOMER UP TO (B)(6) 2023. THE CUSTOMER DID NOT PERFORM ANY PRECISION TESTING ON THE INSTRUMENT SO NO ASSESSMENT OF THE INSTRUMENT PERFORMANCE AT THE TIME OF THE EVENT WAS MADE. ADDITIONALLY, THE ORTHO TSC ESTABLISHED THAT THE REAGENT COOLING HAD SHUT DOWN ON THE INSTRUMENT UP TO FIVE (5) DAYS BEFORE THE DISCORDANT P24 QC FLUID RESULTS WERE OBTAINED. THEREFORE, IT CANNOT BE CONFIRMED THAT THE INSTRUMENT WAS OPERATING AS INTENDED AND UNEXPECTED INSTRUMENT PERFORMANCE AND THE CONDITION OF THE VITROS HIV COMBO REAGENTS CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. VITROS P24 QC FLUID HANDLING, TRANSPORTATION AND STORAGE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT AS IT WAS DETERMINED THAT THE CONTROL FLUID MAY NOT HAVE BEEN SUPPLIED IN THE EXPECTED CONDITION (FROZEN) TO THE CUSTOMER SITE.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT NON-REACTIVE VITROS HIV COMBO RESULTS WERE OBTAINED FROM A REACTIVE VITROS HIV P24 ANTIGEN QC FLUID LOT 0150 WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCTS HIV COMBO (HIVC) REAGENT LOT 0950 IN CONJUNCTION WITH A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS HIV P24 ANTIGEN QC RESULTS OF 0.49, 0.60 AND 0.84 S/C (NEGATIVE) VS. THE EXPECTED RESULT OF REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT VITROS HIV COMBO RESULTS WERE FROM NON-PATIENT FLUID AND WERE NOT REPORTED OUTSIDE THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143053 VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO REAGENT PACK IN-VITRO DIAGNOSTICS MZF ORTHO-CLINICAL DIAGNOSTICS, INC. 0950 10758750031580

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown