BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ STAPHSR

    MDR report key: 16388306 · Received February 16, 2023

    Report

    Report Number
    3007420875-2023-00006
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    February 1, 2021
    Report Date
    March 20, 2023
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    NQX
    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

    H.6 INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE KIT BD MAX¿ STAPHSR (REF. 443419) LOTS 0182260 AND 1279320 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, RETAIN MATERIAL TESTING AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX STAPHSR INDICATED THAT LOTS 0182260 AND 1279320 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE RETAIN MATERIAL OF BD MAX STAPHSR FROM LOT 1279320 WAS TESTED AND THE RESULTS MET THE SPECIFICATIONS. KIT LOT 0182260 COULD NOT BE TESTED SINCE IT IS EXPIRED FOR MORE THAN SIX MONTHS AND THE RETAIN MATERIAL WAS NO LONGER AVAILABLE. CUSTOMER COMPLAINED ABOUT MRSA STRAINS THAT GAVE NEGATIVE RESULTS FOR THE MREJ TARGET WHEN USING BD MAX¿ STAPHSR ASSAY. HOWEVER, WITH GENEXPERT AND ON CULTURE, THEY WERE IDENTIFIED AS MRSA STRAINS. FOUR RUN FILES (751, 890, 1179 AND 1951 FROM INSTRUMENTS (B)(6)) WERE PROVIDED FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS ALL MRSA NEGATIVE RESULTS FOUND IN THE CUSTOMER DATA. MANUAL PCR CURVE ADJUDICATION REVEALED STRONG AMPLIFICATION CURVES FOR THE NUC (VIC) AND THE MEC (ROX) TARGETS BUT NO OR LATE AMPLIFICATION FOR THE MREJ (SCCMEC RIGHT-EXTREMITY JUNCTION) (FAM) TARGET. AS MENTIONED IN THE PACKAGE INSERT P0207, 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 MECA AND MECC HARBORING MRSA STRAINS (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 HAVE BEEN UNDETECTED BY THE BD MAX¿ STAPHSR ASSAY. IT MUST BE NOTED THAT SPA TYPING, SCCMEC AND MREJ TYPING ARE DIFFERENT TYPING METHODS, WITHOUT ANY LINK BETWEEN THEM. WITHOUT ANALYSIS OF THE CUSTOMER STRAIN, BD WAS UNABLE TO CONFIRM THE CUSTOMER ISSUE. NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD MAX STAPHSR ASSAY FROM LOTS 0182260 AND 1279320. THE ROOT CAUSE WAS NOT IDENTIFIED. BD ACKNOWLEDGE THE CUSTOMER ISSUE BUT 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. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER EMAIL: (B)(6). COMMON DEVICE NAME: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MAX¿ STAPHSR DISCREPANT FALSE NEGATIVE RESULTS HAVE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANCY IN RESULTS (FALSE NEGATIVES?) COMPARED TO GENEXPERT MRSA TEST. THERE ARE A NUMBER OF MRSA STRAINS THAT CAUSE PROBLEMS IN THE MRSA TEST ON THE BD MAX. THESE STRAINS GIVE A POSITIVE RESULT FOR MEC A/C AND NUC WITH CT VALUES AROUND 20.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MAX¿ STAPHSR DISCREPANT FALSE NEGATIVE RESULTS HAVE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANCY IN RESULTS (FALSE NEGATIVES?) COMPARED TO GENEXPERT MRSA TEST. THERE ARE A NUMBER OF MRSA STRAINS THAT CAUSE PROBLEMS IN THE MRSA TEST ON THE BD MAX. THESE STRAINS GIVE A POSITIVE RESULT FOR MEC A/C AND NUC WITH CT VALUES AROUND 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557766 BD MAX¿ STAPHSR SEE H.10 NQX GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443419 UNKNOWN 00382904434199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown