BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK

    MDR report key: 13861194 · Received March 23, 2022

    Report

    Report Number
    3007111389-2022-00027
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 19, 2022
    Report Date
    March 22, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT DISCORDANT, FALSE REACTIVE ANTI-HBC (AHBC) RESULTS WERE OBTAINED FROM SAMPLES FROM TWO PATIENTS WHEN TESTED USING VITROS AHBC LOT 2640 ON TWO VITROS ECI IMMUNODIAGNOSTIC SYSTEMS. THE RESULTS WERE DISCORDANT COMPARED TO NON-REACTIVE AHBC RESULTS OBTAINED FROM NON-VITROS (ROCHE) AHBC TESTING. ADDITIONALLY, THE VIRAL HEPATITIS B DNA TESTS FOR THE PATIENTS RETURNED NEGATIVE RESULTS. A DEFINITIVE CAUSE OF THE DISCORDANT, FALSE REACTIVE VITROS AHBC RESULTS WAS NOT ESTABLISHED. A VITROS AHBC LOT 2640 ISSUE IS AN UNLIKELY CONTRIBUTOR TO THE EVENT AS QC RESULTS AROUND THE TIME OF THE EVENT WERE ACCEPTABLE. ADDITIONALLY, ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS AHBC REAGENT LOT 2640. WITHIN RUN DIAGNOSTIC PRECISION TESTING INDICATED ACCEPTABLE PERFORMANCE OF ONE OF THE VITROS ECI IMMUNODIAGNOSTIC SYSTEMS, HOWEVER, NO PRECISION TESTING WAS PERFORMED ON EITHER INSTRUMENT AROUND THE TIME OF THE EVENT. INSTRUMENT ISSUES CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS CONTRIBUTING TO THIS EVENT, AS IT IS UNKNOWN IF THE PATIENT SAMPLES WERE PREPARED IN ACCORDANCE WITH THE TUBE MANUFACTURER¿S RECOMMENDATIONS. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. INTERFERENCE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT AS NO FURTHER INVESTIGATIONAL TESTING TO RULE OUT THE PRESENCE OF AN INTERFERENT WAS CONDUCTED AT THE TIME OF THIS REPORT. IT IS POSSIBLE AN INTERFERENT THAT AFFECTS THE VITROS AHBC METHOD AND NOT THE ROCHE AHBC METHOD CONTRIBUTED TO THE EVENT, BUT THIS COULD NOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT DISCORDANT, FALSE REACTIVE ANTI-HBC (AHBC) RESULTS WERE OBTAINED FROM SAMPLES FROM TWO PATIENTS WHEN TESTED USING VITROS AHBC LOT 2640 ON TWO VITROS ECI IMMUNODIAGNOSTIC SYSTEMS. THE RESULTS WERE DISCORDANT COMPARED TO NON-REACTIVE AHBC RESULTS OBTAINED FROM NON-VITROS (ROCHE) AHBC TESTING. ADDITIONALLY, THE VIRAL HEPATITIS B DNA TESTS FOR THE PATIENTS RETURNED NEGATIVE RESULTS. PATIENT 1, VITROS AHBC RESULT OF 0.98 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NON-REACTIVE. PATIENT 2, VITROS AHBC RESULTS OF 0.66, 0.70, 0.64, 0.68 AND 0.74 S/C (REACTIVE) VERSUS THE EXPECTED RESULT ON NON-REACTIVE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE FALSE REACTIVE VITROS AHBC RESULTS WERE NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO 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 NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129027 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK IN-VITRO DIAGNOSTICS LOM ORTHO-CLINICAL DIAGNOSTICS 2640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown