BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    MDR report key: 20738172 · Received November 20, 2024

    Report

    Report Number
    3007420875-2024-00131
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    October 4, 2024
    Report Date
    February 11, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCH
    UDI-DI
    00382904438128
    PMA / PMN Number
    K214122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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

    INVESTIGATION SUMMARY. THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX EXTENDED ENTERIC BACTERIAL PANEL (XEBP) ASSAY (REF. 443812) KIT LOT 4051425 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER REPORTED A LOW POSITIVE RESULT FOR THE YERSINA ENTEROCOLITICA (YERSINA) TARGET WITH BD MAX XEBP KIT LOT 4051425 THAT RATHER GAVE A POSITIVE RESULT FOR YERSINA FREDERIKSENII WHEN TESTED WITH OTHER METHODS (MALDI-TOF AND WGS) AND IS ASKING ABOUT CROSS-REACTIVITY BETWEEN THE TWO YERSINA STRAINS IN BD MAX XEBP. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX XEBP ASSAY INDICATED THAT LOT 4051425 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUN 163 AND DATABASE FROM INSTRUMENT CT2605 FOR INVESTIGATION. NO SPECIFIC INFORMATION ABOUT THE DISCREPANT SAMPLE WAS PROVIDED. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE TWO POSITIVE RESULTS FOUND IN RUN 163. ONE EXTERNAL POSITIVE CONTROL IN POSITION A1, WHICH GAVE A POSITIVE RESULT FOR THE YERSINA TARGET, AS WELL AS A LATE AND LOW POSITIVE RESULT FOR THE SAMPLE IN POSITION A4, WHICH APPEARED TO BE TRUE FLUORESCENCE DETECTION IN THE FAM CHANNEL IN THE BOTTOM POSITION OF THE CARTRIDGE. A POSITIVE RESULT WAS THE EXPECTED RESULT IN SUCH A CASE. LOW POSITIVE SAMPLES CAN OCCUR DUE TO BACTERIAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. MOREOVER, Y. FREDERIKSENNII WAS TESTED DURING DEVELOPMENT OF THE BD MAX XEBP ASSAY IN THE EXCLUSION STUDY AND WAS NOT DETECTED. ALSO, THE PRIMERS AND PROBES INCLUDED IN THE BD MAX XEBP ASSAY TARGET A GENE SPECIFIC TO Y. ENTEROCOLITICA. ACCORDINGLY, BLASTS OF THE ASSAY PRIMERS SEQUENCES, AGAINST THE Y. FREDERIKSENNII GENOME SEQUENCE, SHOWED NO SIMILARITIES NOR PAIRING. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX XEBP ASSAY LOT 4051425. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), AS WELL AS ENVIRONMENTAL OR CROSS CONTAMINATION COULD EXPLAIN THE CUSTOMER¿S ISSUE. MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT VERIFICATION METHODS. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION SINCE NO NEW HAZARD OR TRENDS WERE IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF KIT BD MAX EXT ENTERIC BACTERIAL PANEL, A MILD FALSE POSITIVE Y. ENTEROCOLITICA PATIENT RESULT WAS OBTAINED. THE CUSTOMER RAN A MALDI-TOF AND A WGS TO DETERMINE THAT THE POSITIVE WAS Y. FREDERIKSENII, NOT Y. ENTEROCOLITICA. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF KIT BD MAX EXT ENTERIC BACTERIAL PANEL, A MILD FALSE POSITIVE Y. ENTEROCOLITICA PATIENT RESULT WAS OBTAINED. THE CUSTOMER RAN A MALDI-TOF AND A WGS TO DETERMINE THAT THE POSITIVE WAS Y. FREDERIKSENII, NOT Y. ENTEROCOLITICA. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054045 KIT BD MAX EXT ENTERIC BACTERIAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4051425 00382904438128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown