BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 19340187 · Received May 17, 2024

    Report

    Report Number
    1119779-2024-00383
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 17, 2024
    Report Date
    April 22, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    NJR
    UDI-DI
    00382904419165
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES. THE INFORMATION FOR EACH ADDITIONAL TYPE IS AS FOLLOWS: D.2. MEDICAL DEVICE TYPE: NQX, OOI, OZN. THERE WERE MULTIPLE PMA/510K NUMBERS: G.5. PMA / 510(K)#: K111860, K120138, K130470. H6. INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT HAD "FALSE POSITIVES". CUSTOMER REPORTED THAT THEY ARE WITNESSING SUSPECTED FALSE POSITIVE RESULTS WHILE RUNNING THE C. DIFF ASSAY. THE CUSTOMER INSTRUMENT RUN DATABASE WAS PROVIDED TO BD SERVICE AND QUALITY FOR FURTHER ANALYSIS WHICH REVEALED TRUE LOW-LEVEL AMPLIFICATION IN THE SUSPECTED FALSE POSITIVE SAMPLES, WHICH WERE RUN ADJACENT TO HIGHLY POSITIVE SPECIMENS. THIS COMPLAINT IS UNCONFIRMED AS THE ROOT CAUSE WAS DETERMINED TO BE DUE TO CONTAMINATION THROUGH HISTORICAL DATABASE ANALYSIS FOR THE INSTRUMENT. THE INSTRUMENT WAS CONFIRMED TO MEET BD SPECIFICATIONS. SAMPLE ANALYSIS CONSISTED OF THE CUSTOMER INSTRUMENT DATABASE. ANALYSIS BY BD QUALITY REVEALED EVIDENCE OF TRUE AMPLIFICATION IN THE LANES OF THE SUSPECTED FALSE POSITIVE RESULTS AND POTENTIAL CONTAMINATION. REVIEW OF THE DEVICE HISTORY RECORD FOR THE INSTRUMENT IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND THE COMPLAINT IS UNCONFIRMED, THUS A DHR REVIEW WOULD YIELD NO USEFUL INFORMATION. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, THERE WAS AN UNSPECIFIED NUMBER OF CLOSTRIDIUM DIFFICILE FALSE POSITIVE PATIENT RESULTS. THE PCR CURVE WAS UNUSUAL, SO THE TEST WAS REPEATED, AND THE RESULT WAS C DIFF NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491347 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS NJR BECTON, DICKINSON & CO. (SPARKS) 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown