BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ STAPHSR

    MDR report key: 22161884 · Received June 6, 2025

    Report

    Report Number
    3007420875-2025-00088
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 7, 2025
    Report Date
    August 6, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN. D2: 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ STAPHSR KIT (REF # 443419) LOT 4233927 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ STAPHSR KIT INDICATED THAT LOT 4233927 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE RETAIN MATERIAL OF BD MAX¿ STAPHSR KIT FROM LOT 4233927 WAS TESTED AND THE RESULTS WERE AS EXPECTED. CUSTOMER COMPLAINED ABOUT A METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) NEGATIVE RESULT WITH BD MAX STAPHSR KIT LOT 4233927 THAT UPON REPEAT TEST WITH A NEW SAMPLE BUFFER TUBE (SBT) INOCULATED WITH THE SAME SWAB, GAVE A POSITIVE MRSA RESULT. CUSTOMER PROVIDED RUN FILES 832 AND 833 FROM BD MAX¿ INSTRUMENT CT3303 FOR THE INVESTIGATION. CUSTOMER IDENTIFIED SAMPLES IN POSITION A7 AS THE DISCREPANT SAMPLE AND SPECIFIED THAT CHANNEL 585/630 (ROX) WAS THE CHANNEL CAUSING THE DISCREPANT RESULTS. BOTH RUNS WERE ANALYZED AND PCR CURVES ADJUDICATION IN THE ROX CHANNEL (MECA/MECC TARGET) REVEALED LATE AND LOW AMPLIFICATION THAT DID NOT REACHED THE THRESHOLD TO GIVE A POSITIVE RESULT FOR SAMPLE A7 (RUN 832), WHILE IT REACHED THE THRESHOLD FOR SAMPLE A7 (RUN 833). 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¿ STAPHSR KIT LOT 4233927. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, SAMPLE AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) IS THE MOST LIKELY CAUSE TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD LIFE SCIENCES QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A FALSE NEGATIVE MRSA PATIENT RESULT WAS OBTAINED. THE SAMPLE TEST WAS MRSA- /SA+ WITH A LOW PCR CURVE. THEY REPEATED THE SAMPLE USING A NEW SBT BUT SAME SWAB, AND RESULT WAS MRSA+ / SA+ WITH A MORE TYPICAL PCR CURVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A FALSE NEGATIVE MRSA PATIENT RESULT WAS OBTAINED. THE SAMPLE SAMPLE TEST WAS MRSA- / SA+ WITH A LOW PCR CURVE. THEY REPEATED THE SAMPLE USING A NEW SBT BUT SAME SWAB, AND RESULT WAS MRSA+ / SA+ WITH A MORE TYPICAL PCR CURVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391757 BD MAX¿ STAPHSR SEE H11 OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4233927 00382904434199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown