BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX ENTERIC VIRAL PANEL

    MDR report key: 13765958 · Received March 15, 2022

    Report

    Report Number
    3007420875-2022-00009
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    February 18, 2022
    Report Date
    April 7, 2022
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCH
    UDI-DI
    00382904439859
    PMA / PMN Number
    K181427
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX ENTERIC VIRAL PANEL ASSAY (REF. 443985) LOT 1251639 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX ENTERIC VIRAL PANEL INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT SEVEN ROV AND ADV POSITIVE SAMPLES WHICH ONLY ONE WAS CONFIRMED AS POSITIVE WITH IMMUNOCHROMATOGRAPHY (WITH NO SPECIFIC TARGET DESCRIPTION). CUSTOMER PROVIDED RUN 367 FROM INSTRUMENT CT0309 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ACROSS ALL THE POSITIVE SAMPLES OF THE RUN PROVIDED. ANALYSIS OF THE PCR CURVES SHOWS LATE AND LOW BUT TRUE AMPLIFICATIONS FOR ROV AND ADV TARGETS WITHOUT ANOMALY INDICATIVE OF TRUE LOW POSITIVES RESULTS, EXCEPT FOR ONE SAMPLE WHICH PRESENTED A STRONGER ROV POSITIVE RESULT. BD SUSPECTS THIS SAMPLE IS THE ONE CONFIRMED BY IMMUNOCHROMATOGRAPHY BUT CANNOT CONFIRM. IT MUST BE NOTED THAT LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS AND DETECTION METHODS. LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX ENTERIC VIRAL PANEL LOT 1251639. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, POSITIVES SAMPLES AT THE LIMIT OF DETECTION OF THE ASSAY OR AN ENVIRONMENTAL / CROSS CONTAMINATION CAN EXPLAIN THE CUSTOMER RESULTS. NONETHELESS, NO REAGENTS ISSUE IS SUSPECTED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) SINCE NO REAGENT ISSUE WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING KIT BD MAX ENTERIC VIRAL PANEL FALSE POSITIVES RESULTS OCCURRED. THIS OCCURRED 7 TIMES. CONFIRMATORY TESTING WAS PERFORMED USING IMMUNOCHROMATOGRAPHY. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVES IN ROTAVIRUS AND ADENOVIRUS. THE CLIENT COMPLAINED BECAUSE THEY PROCESSED 7 SPECIMENS AND THE BD MAX SYSTEM GAVE FALSE POSITIVE RESULTS. ONLY ONE OF THE 7 SPECIMENS WAS CONFIRMED WITH IMMUNOCHROMATOGRAPHY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING KIT BD MAX ENTERIC VIRAL PANEL FALSE POSITIVES RESULTS OCCURRED. THIS OCCURRED 7 TIMES. CONFIRMATORY TESTING WAS PERFORMED USING IMMUNOCHROMATOGRAPHY. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVES IN ROTAVIRUS AND ADENOVIRUS. THE CLIENT COMPLAINED BECAUSE THEY PROCESSED 7 SPECIMENS AND THE BD MAX SYSTEM GAVE FALSE POSITIVE RESULTS. ONLY ONE OF THE 7 SPECIMENS WAS CONFIRMED WITH IMMUNOCHROMATOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696291 KIT BD MAX ENTERIC VIRAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443985 1251639 00382904439859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown