BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 18030577 · Received October 30, 2023

    Report

    Report Number
    3007420875-2023-00100
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    October 5, 2023
    Report Date
    November 21, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. SITE LEGAL NAME (FDA): BECTON, DICKINSON & CO. (SPARKS) D1. MEDICAL DEVICE BRAND NAME: BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT. D2A. COMMON DEVICE NAME: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS. D3. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO. (SPARKS). D4. MEDICAL DEVICE CATALOG #: 441916. D4. MEDICAL DEVICE SERIAL#: (B)(6). D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G1: MANUFACTURING LOCATION: BECTON, DICKINSON & CO. (SPARKS). G5: PMA/510(K)#: K111860, K130470. H4. DEVICE MANUFACTURE DATE: 24-APR-2023. H5. LABELED FOR SINGLE USE: NO. H.6. INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT HAD "DISCREPANT RESULTS." CUSTOMER REPORTED THAT THEY ARE WITNESSING DISCREPANT RESULTS FOR VIBRIO WHILE RUNNING THE EXTENDED ENTERIC BACTERIAL PANEL ASSAY. THE CUSTOMER RUN DATABASE WAS PROVIDED TO BD SERVICE SPECIALISTS AND QUALITY FOR FURTHER ANALYSIS. THIS ANALYSIS REVEALED READER NORMALIZATION RATIOS WHICH ARE OUT OF SPECIFICATION. A BD FIELD SERVICE (FSE) WAS DISPATCHED TO THE CUSTOMER SITE WHERE THEY PERFORMED RE-NORMALIZATION OF BOTH READERS. INSTRUMENT PERFORMANCE WAS QUALIFIED FOLLOWING REPAIR AND WAS CONFIRMED TO BE OPERATIONAL TO BD SPECIFICATIONS. THIS COMPLAINT IS CONFIRMED BY SERVICE & QUALITY. THE ROOT CAUSE WAS TRACED TO AN OPERATIONAL FAILURE OF THE READERS DUE TO A DRIFT IN THE NORMALIZATION RATIOS. SAMPLE ANALYSIS CONSISTED OF CUSTOMER INSTRUMENT RUN DATA FILES. ANALYSIS BY BD QUALITY REVEALED NORMALIZATION RATIOS NOT IN SPECIFICATION FOR THE READERS. DHR REVIEW IS NOT REQUIRED FOR THIS COMPLAINT. THE COMPLAINT WAS EVALUATED VIA OTHER ELEMENTS OF THE INVESTIGATION. THE RESULTS OF THIS EVALUATION HAVE NOT IDENTIFIED ANY NEW HAZARDS, NEW RISKS, OR SPECIFIC TRENDS. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT AND NO ADDITIONAL CASES WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT. NO NEW RISKS OR HAZARDS, OR CHANGES TO EXISTING RISKS/HAZARDS, WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL, THERE WAS A FALSE NEGATIVE OF A PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MAX 442963_3137729 DISCREPANT RESULT FOR VIBRIO BETWEEN (B)(6) THIS WAS A FALSE NEGATIVE AS OUR STOOL CULTURE GREW VIBRIO".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL, THERE WAS A FALSE NEGATIVE OF A PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MAX 442963_3137729 DISCREPANT RESULT FOR VIBRIO BETWEEN CT3205 AND CT3216 THIS WAS A FALSE NEGATIVE AS OUR STOOL CULTURE GREW VIBRIO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889835 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON DICKINSON & CO. (SPARKS) 3137729 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown