BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 12096942 · Received June 30, 2021

    Report

    Report Number
    3007420875-2021-00027
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    May 13, 2021
    Report Date
    December 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904429706
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.5. EVENT DESCRIPTION: IT WAS REPORTED THAT WHILE USING THE BD INSTRUMENT MAX CLINICAL A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. ASSAY USED: BD MAX¿ CT/GC/TV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER REPORTS THAT THEY PERFORMED BOTH THE CT/GC/TV PANEL AND VAGINAL PANEL FOR THE SAME PATIENTS AND THE TV RESULT WAS DIFFERENT." D.1. DEVICE BRAND NAME: BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT D.2. COMMON DEVICE NAME: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS; PRODUCT CODE: OOI D.3. DEVICE MANUFACTURER: BECTON, DICKINSON & CO. (SPARKS) D.4. CATALOG NUMBER: 441916; SERIAL NUMBER: (B)(6); UNIQUE IDENTIFIER: (B)(4). G.1. MANUFACTURING SITE: BECTON, DICKINSON & CO. (SPARKS) G.5. DEVICE 510K NUMBERS: K111860 K130470. H.4. DEVICE MANUFACTURER DATE: 2021-01-20.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A "CORRELATION/REPRO/DISCREPANT" RESULT COMPLAINT WAS REPORTED AGAINST THE BD MAX INSTRUMENT, CATALOG NUMBER 441916, SERIAL NUMBER (B)(6) . CUSTOMER REPORTED THAT THEY RECEIVED A POSITIVE RESULT ON MAX VAGINAL PANEL ON (B)(6) AND A NEGATIVE TV ON CTGCTV ASSAY. BOTH SAMPLES ARE FROM THE SAME PATIENT. FIELD SERVICE WAS DISPATCHED. FIELD SERVICE REPLACED PUMP #2 ON (B)(6) . INSTRUMENT WAS RETURNED TO THE CUSTOMER FUNCTIONAL. NO PARTS WERE RETURNED TO BD. COMPLAINT IS UNCONFIRMED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. INVESTIGATION CONSISTED OF A REVIEW OF THE INSTRUMENT INSTALLATION, SERVICE HISTORY, AND RELATED COMPLAINT DATA. BD WILL CONTINUALLY MONITOR FOR TREND.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: IT WAS REPORTED THAT WHILE USING THE BD INSTRUMENT MAX CLINICAL A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. ASSAY USED: BD MAX¿ CT/GC/TV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER REPORTS THAT THEY PERFORMED BOTH THE CT/GC/TV PANEL AND VAGINAL PANEL FOR THE SAME PATIENTS AND THE TV RESULT WAS DIFFERENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. ASSAY USED: BD MAX¿ CT/GC/TV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER REPORTS THAT THEY PERFORMED BOTH THE CT/GC/TV PANEL AND VAGINAL PANEL FOR THE SAME PATIENTS AND THE TV RESULT WAS DIFFERENT."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD MAX¿ CT/GC/TV A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER REPORTS THAT THEY PERFORMED BOTH THE CT/GC/TV PANEL AND VAGINAL PANEL FOR THE SAME PATIENTS AND THE TV RESULT WAS DIFFERENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988970 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 442970 0307086 00382904429706
    988976 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 442970 0307086 00382904429706

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown