BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 13831033 · Received March 20, 2022

    Report

    Report Number
    1119779-2022-00450
    Event Type
    Injury
    Date Received
    March 20, 2022
    Date of Event
    February 17, 2022
    Report Date
    June 21, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    K111860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. PMA/510K MULTIPLE NUMBERS: K111860, K130470. 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

    H.6 INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT (CATALOG NUMBER 441916 AND SERIAL NUMBER (B)(6)) HAD " TB - DISCREPANT". THE COMPLAINT IS NOT CONFIRMED BECAUSE THE ISSUE DID NOT RE-OCCUR. THE ROOT CAUSE IS "UNKNOWN". REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT (B)(6)IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND HAS CHANGED CONFIGURATION SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. DEVICE WAS INSTALLED ON 5/13/2020. SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION AND THUS, RETURNED MATERIAL INVESTIGATION COULD NOT OCCUR. REVIEW OF SERVICE HISTORY FOR THIS DEVICE DID NOT REVEAL ANY PRIOR EVENTS RELATED TO THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR TRENDS ASSOCIATED WITH THIS FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USE OF BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT; RESULTED IN A FALSE POSITIVE. THE FALSE RESULT WAS REPORTED TO THE CLINICIAN AND RESULTED IN A CHANGE TO THE TO PATIENT TREATMENT. THIS CONSTITUTES A SERIOUS INJURY. CONFIRMATORY TESTS WERE EVENTUALLY RECEIVED GENEXPERT CONFIRMING FALSE RESULTS. THIS WAS A ONE TIME OCCURRENCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PROBLEM 441916 - INSTRUMENT MAX CLINICAL PATIENT SAMPLES - ONCE INH RESISTANCE IS REPORTED AND ONCE RIF RESISTANCE. THIS RESULT COULD NOT BE REPEATED." UPON RECEIVING THE ORIGINAL RESULTS THE CLINICIAN PLACED THE PATIENT ON AN ALTERNATIVE REGIMEN. ONCE THE CLINICIAN "RECEIVED A RESPONSE FROM FHI WITH THE NEGATIVE RESPONSE TO ISONIAZID RESISTANCE, BUT IT IS UNCERTAIN WHETHER THEY WILL CHANGE THE TREATMENT NOW."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USE OF BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT; RESULTED IN A FALSE POSITIVE. THE FALSE RESULT WAS REPORTED TO THE CLINICIAN AND RESULTED IN A CHANGE TO THE TO PATIENT TREATMENT. THIS CONSTITUTES A SERIOUS INJURY. CONFIRMATORY TESTS WERE EVENTUALLY RECEIVED GENEXPERT CONFIRMING FALSE RESULTS. THIS WAS A ONE TIME OCCURRENCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PROBLEM 441916 - INSTRUMENT MAX CLINICAL PATIENT SAMPLES - ONCE INH RESISTANCE IS REPORTED AND ONCE RIF RESISTANCE. THIS RESULT COULD NOT BE REPEATED." UPON RECEIVING THE ORIGINAL RESULTS THE CLINICIAN PLACED THE PATIENT ON AN ALTERNATIVE REGIMEN. ONCE THE CLINICIAN "RECEIVED A RESPONSE FROM FHI WITH THE NEGATIVE RESPONSE TO ISONIAZID RESISTANCE, BUT IT IS UNCERTAIN WHETHER THEY WILL CHANGE THE TREATMENT NOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629250 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 Unknown Required Intervention