BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-307

    MDR report key: 14691155 · Received June 14, 2022

    Report

    Report Number
    1119779-2022-00866
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    February 4, 2022
    Report Date
    July 7, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1306568, MEDICAL DEVICE EXPIRATION DATE: 30NOV2022, DEVICE MANUFACTURE DATE: 02NOV2021. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: K032299, K061355, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K032655, K062944, K060444, K063811, K151320, K063301, K031530, K060447, K023634, K020322, K132674, K023858, K071623, K031699, K060447, K024153, K060214, K042932.

    Additional Manufacturer Narrative · 0

    H.6 THIS MDR HAS BEEN RE-EVALUATED AND HAS BEEN FOUND TO BE NOT REPORTABLE. THE EVENT WAS A CAP SURVEY AND THEREFORE NOT REPORTABLE. THIS MDR IS TO BE CONSIDERED CANCELED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD PHOENIX PANEL NMIC-307 THE RESULTS REPORTED WERE NOT WHAT WAS EXPECTED. CONFIRMATORY TESTING WAS PERFORMED USING REPEAT TESTING. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: * HOW MANY PASSES FROM LYOPHILIZED ISOLATE WERE PERFORMED PRIOR TO ID/AST TESTING? WE DID NOT SUBCULTURE THE ISOLATE. IT WAS REPORTED BY THE CUSTOMER THAT THERE IS A SURVEY FAILURE. CUSTOMER PROBLEM: CUSTOMER REPORTS CAP SURVEY FAILURE FOR 449283 LOTS 1306568 AND 2067257. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: OPENED A COMPLAINT. CUSTOMER REPORTS FAILURE ON SURVEY D-(B)(6) 2022. EXPECTED RESULT: PROTEUS MIRABILIS, AMPICILLIN RESISTANT. PHOENIX RESULT: PROTEUS MIRABILIS, AMPICILLIN SENSITIVE. CUSTOMER FIRST RAN THE SAMPLE ON 2/4 AND SUBMITTED RESULTS TO CAP. RECEIVED RESULTS THAT AMPICILLIN RESULT WAS INCORRECT. FACILITY REPORTED S BUT EXPECTED RESULT WAS R. CUSTOMER RE-RAN SAMPLE ON PHOENIX SERIAL (B)(4) A FEW DAYS AGO AND OBTAINED THE SAME RESULT AS THE FIRST TIME. CUSTOMER RAN AN ALTERNATIVE METHOD AND OBTAINED A SENSITIVE RESULT. CUSTOMER REPORTS CAP SURVEY FAILURE FOR 449283 LOTS 1306568 AND 2067257.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD PHOENIX PANEL NMIC-307 THE RESULTS REPORTED WERE NOT WHAT WAS EXPECTED. CONFIRMATORY TESTING WAS PERFORMED USING REPEAT TESTING. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: * HOW MANY PASSES FROM LYOPHILIZED ISOLATE WERE PERFORMED PRIOR TO ID/AST TESTING? WE DID NOT SUBCULTURE THE ISOLATE. IT WAS REPORTED BY THE CUSTOMER THAT THERE IS A SURVEY FAILURE. CUSTOMER PROBLEM: CUSTOMER REPORTS CAP SURVEY FAILURE FOR 449283 LOTS 1306568 AND 2067257 STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: OPENED A COMPLAINT. CUSTOMER REPORTS FAILURE ON SURVEY D-01 2022. EXPECTED RESULT: PROTEUS MIRABILIS, AMPICILLIN RESISTANT PHOENIX RESULT: PROTEUS MIRABILIS, AMPICILLIN SENSITIVE CUSTOMER FIRST RAN THE SAMPLE ON (B)(6) AND SUBMITTED RESULTS TO CAP. RECEIVED RESULTS THAT AMPICILLIN RESULT WAS INCORRECT. FACILITY REPORTED S BUT EXPECTED RESULT WAS R. CUSTOMER RE-RAN SAMPLE ON PHOENIX SERIAL (B)(6)A FEW DAYS AGO AND OBTAINED THE SAME RESULT AS THE FIRST TIME. CUSTOMER RAN AN ALTERNATIVE METHOD AND OBTAINED A SENSITIVE RESULT CUSTOMER REPORTS CAP SURVEY FAILURE FOR 449283 LOTS 1306568 AND 2067257

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627704 BD PHOENIX PANEL NMIC-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 2067257

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown