BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-305

    MDR report key: 17138606 · Received June 15, 2023

    Report

    Report Number
    1119779-2023-00671
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 24, 2023
    Report Date
    August 14, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED: B5. REPORT 1 OF 2 IT WAS REPORTED THAT DURING USE WITH THE BD PANEL PHOENIX NMIC-305, ENTEROBACTER CLOACAE WAS MISIDENTIFIED AS CITROBACTER FARMERII. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? ACCESSION 1 ISOLATE 1-CITROBACTER FARMERI 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) ACCESSION 1 ISOLATE 1 - ENTEROBACTER CLOACAE REPEATED ON PHOENIX. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? NO - PATIENT SPECIMENS CUSTOMER HAS ADVISED NO TREATMENT CHANGE HAS OCCURRED AS A RESULT OF THE MISIDENTIFICATIONS. D1. BRAND NAME: BD PANEL PHOENIX NMIC-305 D4. MEDICAL DEVICE CATALOG #: 449294 MEDICAL DEVICE LOT #: 2298959 MEDICAL DEVICE EXPIRATION DATE: 17-OCT-2023 UDI: (B)(4) G5. PMA / 510(K)#: THE BD PHOENIX NMIC-305 IS AN ANTIMICROBIAL RESISTANCE PANEL CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K181665, K190905, K032655, K062944, K060444, K173252, K033362, K062207, K063811, K163637, K151320, K063301, K031530, K060447, K032567, K060257, K023634, K123404, K020322, K132674, K173523, K063486, K023858, K031699, K060447, K132909, K042932 H4. DEVICE MANUFACTURE DATE: 25-OCT-2022 H3. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR GRAM NEGATIVE MISIDENTIFICATION WHEN USING PHOENIX PANEL NMIC/ID-307 ((B)(4)) BATCH NUMBERS 2298959 AND 3059859. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS OR ISOLATES BUT DID PROVIDE LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. NOTE BATCH #2298959 CORRESPONDS TO PANEL #(B)(4) NMIC-305. BATCH #2298959 WAS UNAVAILABLE AT THE TIME OF COMPLAINT INVESTIGATION. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH 3059859 WERE TESTED USING QC (A25922) AND IN HOUSE ((B)(4)) E. COLI ISOLATES AND EVALUATED FOR IDENTIFICATION RESULTS. DURING INVESTIGATION, ALL PANELS TESTED WITH THE QC AND IN HOUSE ISOLATES E. COLI ISOLATES IDENTIFIED CORRECTLY. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR E. COLI MIS IDS. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCHES. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 2298959. A REVIEW OF COMPLAINTS REVEALED TWO ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 3059859; NEITHER OF WHICH WAS CONFIRMED. ALTHOUGH WE DIDN'T SEE THE ISSUE DURING COMPLAINT INVESTIGATION TESTING, WE RECOGNIZED THROUGH COMPLAINT TRENDING AN INCREASE OF E. COLI MIS IDS OVER THE PAST YEAR. THE TECHNICAL TEAM HAS IDENTIFIED A POTENTIAL ENHANCEMENT THAT WOULD BOLSTER THE INSTRUMENT¿S ABILITY TO INTERPRET THE BEHAVIOR OF THE ORGANISM¿S INTERACTION WITH THE SUBSTRATES ON THE PANEL. ADDITIONALLY, THE TRENDING FOR P. MIRABILIS WAS REVIEWED AND DOES NOT SHOW THE SAME INCREASE AS E. COLI. HOWEVER, BD IS STILL ASSESSING THE FEASIBILITY OF POSSIBLE IMPROVEMENTS FOR OTHER COMMON GRAM-NEGATIVE ORGANISMS. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS DEFECT, INCLUDING CHANGES IN SEVERITY AND RATE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. G5. PMA / 510(K)#: THE BD PHOENIX NMIC-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: 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, AND K042932. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING CORRECTIONS WERE MADE: TWO POSSIBLE PRODUCT AND LOT NUMBERS WERE PROVIDED: D4. MEDICAL DEVICE CATALOG #: 449289. D4. MEDICAL DEVICE LOT #: 3059859. D4. MEDICAL DEVICE EXPIRATION DATE: 20-FEB-2024. H4. DEVICE MANUFACTURE DATE: 28-FEB-2023. D4. MEDICAL DEVICE CATALOG #: 449294. D4. MEDICAL DEVICE LOT #: 2298959. D4. MEDICAL DEVICE EXPIRATION DATE: 17-OCT-2023. H4. DEVICE MANUFACTURE DATE: 25-OCT-2022. B5. IT WAS REPORTED WHILE USING PANEL PHOENIX NMIC/ID-307 OR PANEL PHOENIX NMIC-305, A PATIENT SPECIMEN WAS MISIDENTIFED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 1 OF 2 IT WAS REPORTED THAT DURING USE WITH THE BD PANEL PHOENIX NMIC-305, ENTEROBACTER CLOACAE WAS MISIDENTIFIED AS CITROBACTER FARMERII. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? ACCESSION 1 ISOLATE 1-CITROBACTER FARMERI 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) ACCESSION 1 ISOLATE 1 - ENTEROBACTER CLOACAE REPEATED ON PHOENIX. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? NO - PATIENT SPECIMENS CUSTOMER HAS ADVISED NO TREATMENT CHANGE HAS OCCURRED AS A RESULT OF THE MISIDENTIFICATIONS.

    Description of Event or Problem · 0

    REPORT 1 OF 2. IT WAS REPORTED THAT DURING USE WITH THE PANEL PHOENIX NMIC/ID-307, ENTEROBACTER CLOACAE WAS MISIDENTIFIED AS CITROBACTER FARMERII. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? ACCESSION 1 ISOLATE 1-CITROBACTER FARMERI. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) ACCESSION 1 ISOLATE 1 - ENTEROBACTER CLOACAE REPEATED ON PHOENIX. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? NO - PATIENT SPECIMENS. CUSTOMER HAS ADVISED NO TREATMENT CHANGE HAS OCCURRED AS A RESULT OF THE MISIDENTIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PANEL PHOENIX NMIC/ID-307 OR PANEL PHOENIX NMIC-305, A PATIENT SPECIMEN WAS MISIDENTIFED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778715 BD PANEL PHOENIX NMIC-305 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 449289 2298959 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown