BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 22816234 · Received August 15, 2025

    Report

    Report Number
    1119779-2025-03410
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 17, 2025
    Report Date
    February 16, 2026
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT HAD "FALSE POSITIVES." CUSTOMER REPORTED THAT THEY WITNESSED A SUSPECTED FALSE POSITIVE RESULT WHILE RUNNING THE COVID ASSAY. RESULT REPORTED STATED POSITIVE FOR A SAMPLE AND WHEN THE CUSTOMER REVIEWED THE PCR GRAPH, THE CURVE WAS NOT OBSERVED TO BE CONSISTENT WITH A POSITIVE RESULT. CUSTOMER ALSO REPORTS THAT THE INSTRUMENT IS MAKING LOUD NOISES WHILE PROCESSING SAMPLES. A BD FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO PERFORM AN INSTRUMENT HEALTH CHECK AND PREVENTATIVE MAINTENANCE (PM) SERVICE. MULTIPLE SUB-ASSEMBLIES WERE FOUND TO BE DEFECTIVE AND WERE REPLACED. THIS INCLUDED THE XY GANTRY CONTROLLER AND 2 Z-GANTRY PUMPS ON PIPETTE 3 AND 4. THE INSTRUMENT WAS CALIBRATED AND QUALIFICATION TESTING WAS PERFORMED AND PASSED. THIS COMPLAINT IS CONFIRMED BY QUALITY. THE ROOT CAUSE OF THE ISSUE WAS TRACED TO INSTRUMENT COMPONENT FAILURES. SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION AND THUS, RETURNED MATERIAL INVESTIGATION COULD NOT OCCUR. IF SAMPLES ARE RECEIVED AT A LATER DATE, THE COMPLAINT MAY BE REOPENED. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT IS NOT REQUIRED AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALL OF THE INSTRUMENT AND THE COMPLAINT WAS CONFIRMED THROUGH OTHER MEANS. 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.

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: NQX, NJR, OZN. G.4. THERE WERE MULTIPLE PMA/510K NUMBERS: K111860, K120138, K130470. 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

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, A FALSE POSITIVE SARS-COV-2 RESULT WAS OBTAINED WITH AN UNUSUAL PCR CURVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, A FALSE POSITIVE SARS-COV-2 RESULT WAS OBTAINED WITH AN UNUSUAL PCR CURVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107260 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown