BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ STAPHSR

    MDR report key: 23350483 · Received October 21, 2025

    Report

    Report Number
    3007420875-2025-00186
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 22, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904434199
    PMA / PMN Number
    K132822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ STAPHSR KIT (REF. (B)(4)) LOT 5029998 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE REVIEW OF QUALITY CONTROL RECORDS OF BD MAX¿ STAPHSR LOT 5029998 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. CUSTOMER COMPLAINED ABOUT DISCREPANT RESULTS FOR THE MREJ TARGET AND THE MECA/C TARGET, WHICH WAS CONFIRMED AS SENSITIVE USING AN ALTERNATIVE METHOD (GENEXPERT®). ADDITIONAL DISCREPANCIES OCCURRED FOR MREJ, NUC, AND MECA/C TARGETS, ALL OF WHICH TESTED NEGATIVE UPON REPEAT TESTING. THE RETAIN MATERIAL OF BD MAX¿ STAPHSR FROM LOT 5029998 WAS TESTED AND THE RESULTS WERE AS EXPECTED. CUSTOMER PROVIDED DATABASE FROM BD MAX¿ INSTRUMENT CT0171 FOR INVESTIGATION, AND IDENTIFIED SAMPLES WITH MREJ ISSUE IN POSITIONS B1 (RUN 5722), B1 (RUN 5724), B1 (RUN 5736), A2 (RUN 5746; REPEATED IN RUN 5748 POSITION A1 WITH SAME RESULT: SA POS/MRSA NEG), AND NUC ISSUE IN POSITION A3 (RUN 5746; REPEATED IN RUN 5748 POSITION A2 WITH DISCREPANT RESULT: SA POS/MRSA NEG). DATABASES ANALYSIS REVEALED VARIATIONS IN RATE OF NEGATIVE RESULTS FOR THE MREJ TARGET (FAM CHANNEL) IN TIME WITH NO APPARENT LINK WITH LOTS, INSTRUMENT LANE OR DECK. PCR CURVES ANALYSIS OF SAMPLES B1 (RUN 5722), B1 (RUN 5724), B1 (RUN 5736) AND A2 (RUN 5746; REPEATED IN RUN 5748 POSITION A1) REVEALED NO AMPLIFICATION IN THE FAM CHANNEL (MREJ TARGET), WHILE THE OTHER CHANNELS SHOWED AMPLIFICATION, FOR ALL THE SAMPLES. A MRSA NEGATIVE RESULT IS EXPECTED IN SUCH CASES. FOR SAMPLE A3 (RUN 5746) ANALYSIS REVEALED HIGHER INITIAL FLUORESCENCE IN ALL THE CHANNELS, WHICH SUGGESTS AN ISSUE OCCURRED DURING SAMPLE PREPARATION BY THE INSTRUMENT AND COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS FOR THE NUC TARGET. NEVERTHELESS, IT APPEARS TO HAVE BEEN ISOLATED TO THIS EVENT. IT MUST BE NOTED THAT MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES IS A CONSERVATIVE ASSESSMENT OF THE DATA. AS MENTIONED IN THE PACKAGE INSERT, THE BD MAX¿ STAPHSR ASSAY IS DESIGNED TO DETECT MREJ GENOTYPES I, II, III, IV, V, VI, VII, IX, XIII, XIV, AND XXI WHICH REPRESENT MOST OF MRSA STRAINS HARBORING MECA AND MECC GENES (BELONGING TO DIFFERENT SCCMEC/MREJ TYPES) ACCOUNTING FOR MORE THAN 98% OF WORLDWIDE STRAINS TESTED BY BD TO DATE. THE INVESTIGATION SUGGESTS THAT THE CUSTOMER STRAIN MAY CORRESPOND TO A MREJ TYPE UNDETECTED BY THE BD MAX¿ STAPHSR ASSAY. WITHOUT ANALYSIS OF THE CUSTOMER STRAIN, BD WAS UNABLE TO CONFIRM THE CUSTOMER ISSUE. MOREOVER, IT MUST BE NOTED THAT SCCMEC AND MREJ TYPING ARE DIFFERENT TYPING METHODS, WITHOUT ANY LINK BETWEEN THEM. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ STAPHSR ASSAY FROM LOT 5029998. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) SINCE NO NEW HAZARD WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN. D.2. ADDITIONAL MEDICAL DEVICE TYPE: NQX. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 3 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A DISCREPANT PATIENT RESULT WAS OBTAINED. SAMPLE WAS TESTED ON GENEXPERT AND MAX RESULT WAS NOT CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 3 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A DISCREPANT PATIENT RESULT WAS OBTAINED. SAMPLE WAS TESTED ON GENEXPERT AND MAX RESULT WAS NOT CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817464 BD MAX¿ STAPHSR SEE H11 OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5029998 00382904434199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown