BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 16569482 · Received March 18, 2023

    Report

    Report Number
    1119779-2023-00297
    Event Type
    Malfunction
    Date Received
    March 18, 2023
    Date of Event
    November 30, 2022
    Report Date
    June 20, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    K111860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS. PMA / 510(K)#: K111860, K130470. 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

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2023-00297 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION. PLEASE SEE PR 6909840 TO SEE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THAT THERE WAS FALSE POSTIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6), DCHU 09-MAR-23: FROM (B)(4), MAX EPP, 442960, GIARDIA FP: CUSTOMER ALLEGING FALSE POSITIVE GIARDIA RESULTS ON EPP CAT: 442960. CUSTOMER STATED 12 PATIENT RESULTS WERE CONFIRMED AS FALSE POSITIVES BY REVIEWING AMPLIFICATION CURVES. REPEATING FROM SAME SBT (PRODUCED A NEGATIVE RESULT ON REPEAT). CONFIRMED WITH CONCENTRATE AND HEMATOXYLIN SLIDE BY MICROSCOPY DONE PRIOR TO REPORTING ANY RESULTS. EMS ARE RAN ON A WEEKLY BASIS. CUSTOMER ENCOUNTERED ¿ERROR IN RESULT METRIC¿ WITH ONE OF THE FALSE POSITIVE GIARDIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THAT THERE WAS FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AMY HOOVER, DCHU (B)(6) 23. FROM PR 6909840 - MAX EPP - 442960 - GIARDIA FP: CUSTOMER ALLEGING FALSE POSITIVE GIARDIA RESULTS ON EPP CAT 442960. CUSTOMER STATED 12 PATIENT RESULTS WERE CONFIRMED AS FALSE POSITIVES BY REVIEWING AMPLIFICATION CURVES REPEATING FROM SAME SBT (PRODUCED A NEGATIVE RESULT ON REPEAT). CONFIRMED WITH CONCENTRATE AND HEMATOXYLIN SLIDE BY MICROSCOPY DONE PRIOR TO REPORTING ANY RESULTS. EMS ARE RAN ON A WEEKLY BASIS. CUSTOMER ENCOUNTERED ¿ERROR IN RESULT METRIC¿ WITH ONE OF THE FALSE POSITIVE GIARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999129 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT SEE H.10 OOI BECTON, DICKINSON & CO. (SPARKS) 441916 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown