BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK

    MDR report key: 16591918 · Received March 22, 2023

    Report

    Report Number
    3007111389-2023-00047
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    February 24, 2023
    Report Date
    March 22, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    LOM
    UDI-DI
    10758750002795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT DISCORDANT REACTIVE VITROS ANTI-HBC IGM (AHBCM) AND ANTI-HAV IGM (AHAVM) RESULTS OBTAINED FROM TWO SAMPLES COLLECTED FROM THE SAME PATIENT COMPARED TO ANTI-HBC TOTAL AND ANTI-HAV TOTAL NEGATIVE RESULTS WERE OBTAINED FROM THE SAME PATIENT SAMPLES WHEN TESTED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS MOST LIKELY AN UNKNOWN SAMPLE INTERFERENT THAT AFFECTS THE VITROS AHAVM AND VITROS AHBCM ASSAYS BUT NOT THE VITROS AHBC TOTAL AND VITROS AHAV TOTAL ASSAYS. THE CUSTOMER PERFORMED A MANUAL 20X DILUTION ON SAMPLE 1, BUT DID NOT PROGRAM A 20X DILUTION FACTOR AND OBTAINED VITROS AHAVM AND AHBCM NEGATIVE RESULTS. THIS INDICATES A POTENTIAL SAMPLE INTERFERENT THAT WAS DILUTED OUT OF THE SAMPLE. THE AFFECTED SAMPLE WAS SENT TO THE MAYO CLINIC TO BE TESTED WITH THE ANTI-HBC TOTAL, ANTI-HAV TOTAL, ANTI-HBC IGM AND ANTI-HAV IGM ASSAYS. THE RESULTS OBTAINED FROM THE MAYO CLINIC MATCHED THE VITROS RESULTS OBTAINED FROM THE SAME FOUR ASSAYS. HOWEVER, IT WAS DETERMINED THE MAYO CLINIC ALSO USED VITROS ASSAYS. THIS SUPPORTS THE LIKELIHOOD OF AN UNKNOWN SAMPLE INTERFERENT THAT AFFECTS THE VITROS AHAVM AND AHBCM ASSAYS BUT NOT THE AHAVT AND AHBCT ASSAYS. HISTORIC QUALITY CONTROL RESULTS WERE ACCEPTABLE INDICATING VITROS AHAVM REAGENT LOT 5730, AHAVT REAGENT LOT 5810, AHBCM REAGENT LOT 8430 AND AHBCT REAGENT LOT 8280 WERE PERFORMING AS INTENDED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT REACTIVE VITROS ANTI-HBC IGM (AHBCM) AND ANTI-HAV IGM (AHAVM) RESULTS OBTAINED FROM TWO SAMPLES COLLECTED FROM THE SAME PATIENT COMPARED TO ANTI-HBC TOTAL AND ANTI-HAV TOTAL NEGATIVE RESULTS WERE OBTAINED FROM THE SAME PATIENT SAMPLES WHEN TESTED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. SAMPLE 1 VITROS AHAVM RESULT OF 10.4 S/C VS. A VITROS AHAV TOTAL NEGATIVE RESULT. SAMPLE 1 VITROS AHBCM RESULT OF 2.87 S/C VS. A VITROS AHBC TOTAL NEGATIVE RESULT. SAMPLE 2 VITROS AHAVM RESULT OF 10.4 S/C VS. A VITROS AHAV TOTAL NEGATIVE RESULT. SAMPLE 2 VITROS AHBCM RESULT OF 2.91 S/C VS. A VITROS AHBC TOTAL NEGATIVE RESULT. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS AHBCM AND AHAVM REACTIVE RESULTS WERE REPORTED OUTSIDE THE LABORATORY BASED ON THE CONCORDANT RESULTS OBTAINED AT THE MAYO CLINIC. THERE WAS NO REPORTED ALLEGATION OF HARM AS A RESULT OF THIS EVENT. 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 (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455480 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK IN-VITRO DIAGNOSTICS LOM ORTHO-CLINICAL DIAGNOSTICS, INC. 6801425 8430 10758750002795

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown