BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 13743071 · Received March 12, 2022

    Report

    Report Number
    1119779-2022-00425
    Event Type
    Malfunction
    Date Received
    March 12, 2022
    Date of Event
    February 17, 2022
    Report Date
    April 27, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA / 510(K)#: THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED: K111860. 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

    H6. THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT (CATALOG NUMBER 441916 AND SERIAL NUMBER (B)(6) HAD "FALSE POSITIVES". CUSTOMER REPORTED THAT THEY ARE SEEING NOISY PCR CURVES WITH SUSPECTED FALSE POSITIVE RESULTS WHILE RUNNING THE MDR TB ASSAY. A BD FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE WHERE THEY PERFORMED READER NORMALIZATION, CALRACK, AND VERIFIED INSTRUMENT ALIGNMENTS. A QUALIFICATION RUN WAS PERFORMED AND PASSED. THIS COMPLAINT IS NOT CONFIRMED AS THERE WAS NO CONFIRMED FAILURE OF THE INSTRUMENT. THE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO SAMPLES WERE EXPECTED TO BE RECEIVED AS PART OF THIS COMPLAINT, AND THEREFORE NO SAMPLES WERE RETURNED, AND NO RETURNED MATERIAL INVESTIGATION COULD OCCUR. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE A FAILURE OF THE INSTRUMENT AND THE COMPLAINT IS UNCONFIRMED, THUS A DHR REVIEW WOULD YIELD NO USEFUL INFORMATION. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6) , AND NO ADDITIONAL WORK ORDERS 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 TESTING WITH THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTING WAS PERFORMED, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. ASSAYS USED: MDR TB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS CUSTOMER IS EXPERIENCING CONSISTENT FALSE ¿LOW POS¿ RESULT. FOR THE PATIENT SAMPLE, UPON REPEAT ON ANOTHER POSITION IT CAME UP NEGATIVE. TO TEST THIS OUT THE CUSTOMER RAN NEGATIVE CONTROL (STERILE WATER) ON B10 AND THIS ALSO CAME UP ¿LOW POS¿. THE CURVE FOR 475/520 CHANNEL LOOKS STRANGE AND DOES NOT LOOK LIKE A REAL AMPLIFICATION CURVE. ON SITE WE PERFORMED SELFTEST ¿ IT PASSED ¿ AND THE PCR.SCRIPT TEMPERATURE PROFILE ALSO LOOKED OK. CUSTOMER IS HAVE AN ISSUE WITH ONE OF THE LANE GIVING CONSISTENTLY FALSE POSITIVE RESULT. THEY ARE RUNNING THE MDR TB ASSAY THE TEST CURVE RESULT LOOKS NOISY AND NOT REAL, CHECK FILL LOOKS OK AND THERE¿S NO BUBBLE IN THE CARTRIDGE CURRENTLY BLOCK B10 LANE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTING WAS PERFORMED, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. ASSAYS USED: MDR TB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS CUSTOMER IS EXPERIENCING CONSISTENT FALSE ¿LOW POS¿ RESULT ON B10. FOR THE PATIENT SAMPLE, UPON REPEAT ON ANOTHER POSITION IT CAME UP NEGATIVE. TO TEST THIS OUT THE CUSTOMER RAN NEGATIVE CONTROL (STERILE WATER) ON B10 AND THIS ALSO CAME UP ¿LOW POS¿. THE CURVE FOR 475/520 CHANNEL LOOKS STRANGE AND DOES NOT LOOK LIKE A REAL AMPLIFICATION CURVE. ON SITE WE PERFORMED SELFTEST ¿ IT PASSED ¿ AND THE PCR.SCRIPT TEMPERATURE PROFILE ALSO LOOKED OK. CUSTOMER IS HAVE AN ISSUE WITH ONE OF THE LANE GIVING CONSISTENTLY FALSE POSITIVE RESULT. THEY ARE RUNNING THE MDR TB ASSAY THE TEST CURVE RESULT LOOKS NOISY AND NOT REAL, CHECK FILL LOOKS OK AND THERE¿S NO BUBBLE IN THE CARTRIDGE CURRENTLY BLOCK B10 LANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972686 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 441916 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown