BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK

    MDR report key: 9181372 · Received October 11, 2019

    Report

    Report Number
    3007111389-2019-00150
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    August 28, 2019
    Report Date
    October 10, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT, FALSE (B)(6) VITROS (B)(6) RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM AND THREE VITROS 3600 IMMUNODIAGNOSTIC SYSTEMS. THE RESULTS WERE DISCORDANT COMPARED TO (B)(6) RESULTS OBTAINED FROM AN ABBOTT METHOD. A DEFINITIVE CAUSE OF THE DISCORDANT, FALSE (B)(6) VITROS (B)(6) RESULTS WAS NOT ESTABLISHED. METHOD TO METHOD DIFFERENCES BETWEEN THE VITROS (B)(6) REAGENT AND THE ABBOTT (B)(6) ASSAY CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. IT IS POSSIBLE THAT THE VITROS (B)(6) REAGENT IS A LESS SENSITIVE METHOD FOR TESTING FOR ANTIBODIES TO THE (B)(6) CORE ANTIGEN, OWING TO THE HIGHER VITROS (B)(6) RESULTS THAT BREACH THE IFU INTERPRETATION FOR A (B)(6) RESULT. A VITROS (B)(6) REAGENT ISSUE IS AN UNLIKELY CONTRIBUTOR TO THE EVENT, AS QUALITY CONTROL RESULTS BEFORE AND AROUND THE TIME OF THE EVENT WERE WITHIN ACCEPTABLE GUIDELINES ON ALL FOUR VITROS INSTRUMENTS. ADDITIONALLY, ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS (B)(6) LOT 2420 AND VITROS (B)(6) LOT 2430. THERE WAS NO INDICATION OF A VITROS INSTRUMENT MALFUNCTION HOWEVER DIAGNOSTIC WITHIN RUN PRECISION TESTING WAS NOT COMPLETED TO EVALUATE THE PERFORMANCE. THEREFORE, A VITROS 5600 OR 3600 SYSTEM ISSUE CANNOT BE ENTIRELY RULED OUT. 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 MANUFACTURERS RECOMMENDATIONS. TURBIDITY IN PATIENT SAMPLES CAN AFFECT VITROS (B)(6) RESULTS. HOWEVER, TURBIDITY CAN BE RULED OUT AS A CAUSE OF THE EVENT, AS THE TURBIDITY INDEX FOR EACH PATIENT SAMPLE DID NOT INDICATE THAT SAMPLES WERE TURBID. ADDITIONALLY, NON-SPECIFIC ANTIBODY INTERFERENCE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. VITROS (B)(6) TESTING COULD NOT BE CARRIED OUT USING NABTS AS THERE WAS NO PATIENT SAMPLE REMAINING. IT IS POSSIBLE THAT AN UNKNOWN INTERFERENT WAS CAUSING FALSE (B)(6) VITROS (B)(6) RESULTS, ALTHOUGH THIS COULD NOT BE DETERMINED. THE (B)(6) VITROS (B)(6) 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.

    Description of Event or Problem · 1

    ON 12 SEPTEMBER 2019, A CUSTOMER CONTACTED THE ORTHO (ORTHO CLINICAL DIAGNOSTICS) TECHNICAL SOLUTIONS CENTRE (TSC) TO REPORT DISCORDANT, (B)(6) VITROS (B)(6) RESULTS WHEN TESTING MULTIPLE PATIENT SAMPLES ON A VITROS 5600 INTEGRATED SYSTEM AND THREE VITROS 3600 IMMUNODIAGNOSTIC SYSTEMS. THE RESULT WERE DISCORDANT WHEN COMPARED TO THE (B)(6) RESULTS TESTED ON AN ABBOTT ARCHITECT SYSTEM. THE FIRST EVENT OCCURRED (B)(6) 2019. VITROS (B)(6) LOT 2420 RESULTS: PATIENT 1 VITROS (B)(6) RESULT OF (B)(6) VS THE ABBOTT RESULT OF (B)(6). PATIENT 6 VITROS (B)(6) RESULT OF(B)(6) VS THE ABBOTT RESULT OF (B)(6). VITROS (B)(6) LOT 2430 RESULTS: PATIENT 2 VITROS (B)(6) RESULT OF(B)(6) VS THE ABBOTT RESULT OF (B)(6); PATIENT 3 VITROS (B)(6) RESULT OF (B)(6) VS THE ABBOTT RESULT OF (B)(6); PATIENT 4 VITROS (B)(6) RESULT OF (B)(6)VS THE ABBOTT RESULT OF(B)(6); PATIENT 5 VITROS (B)(6) RESULT OF (B)(6) VS THE ABBOTT RESULT OF(B)(6); PATIENT 7 VITROS (B)(6) RESULT OF (B)(6) VS THE ABBOTT RESULT OF (B)(6); PATIENT 8 VITROS (B)(6) RESULT OF (B)(6) VS THE ABBOTT RESULT OF (B)(6); PATIENT 9 VITROS (B)(6) RESULT OF (B)(6) VS THE ABBOTT RESULT OF(B)(6); PATIENT 10 VITROS (B)(6) RESULT OF (B)(6) VS THE ABBOTT RESULT OF (B)(6); PATIENT 11 VITROS (B)(6) RESULT OF (B)(6) VS THE ABBOTT RESULT OF (B)(6); PATIENT 13 VITROS (B)(6) RESULT OF (B)(6) VS THE ABBOTT RESULT OF (B)(6); PATIENT 14 VITROS (B)(6) RESULT OF(B)(6) VS THE ABBOTT RESULT OF (B)(6); PATIENT 16 VITROS (B)(6) RESULT OF (B)(6) VS THE ABBOTT RESULT OF (B)(6). 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 RESULTS WERE OBTAINED ON MULTIPLE DIFFERENT PATIENT SAMPLES. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER 1 OF 10 MDRS FOR THIS EVENT. TEN (10) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 10 DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977092 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK IN VITRO DIGANOSTICS LOM ORTHO-CLINICAL DIAGNOSTICS 2420

    Patients

    Seq Age Sex Outcome Treatment
    1