BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 18141145 · Received November 15, 2023

    Report

    Report Number
    1119779-2023-01236
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 16, 2023
    Report Date
    March 18, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    K181665
    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

    H3. 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

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBERS 2291573, 2308989, 3088495, 3115740, 3213033 AND 3213335. THE CUSTOMER DID NOT RETURN ISOLATES OR PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. REVIEW OF THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW MISIDENTIFICATION OF ESCHERICHIA COLI, PROTEUS MIRABILIS, KLEBSIELLA PNEUMONIAE, PSEUDOMONAS ALCALIGENES, ENTEROBACTER CLOACAE COMPLEX, ACINETOBACTER URSINGII, ACINETOBACTER JUNII, KLEBSIELLA OXYTOCA AND CITROBACTER BRAAKII . IT IS TO BE NOTED THAT THE PHOENIX ID SYSTEM DOES NOT HAVE ID CLAIMS FOR P. ALCALIGENES, A. URSINGII OR A. JUNII. COMPLAINT BATCHES 2291573 AND 2308989 WERE BEYOND EXPIRATION AND UNABLE TO BE TESTED AT THE TIME OF THE INVESTIGATION. TO INVESTIGATE, RETENTION PANELS EACH FROM COMPLAINT BATCHES 3088495, 3115740, 3213033 AND 3213335 WERE TESTED USING IN HOUSE ISOLATES E. COLI (ENF9924), P. MIRABILIS (ENF9912). IN ADDITION, CONTROL PANELS FROM THE SAME MATERIAL (449289) BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATE E. COLI (ENF9924) AND P. MIRABILIS (ENF9912). ALL PANELS WERE LOADED INTO A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS IDENTIFIED CORRECTLY AS EITHER E. COLI OR P. MIRABILIS. RETENTION PANELS FROM COMPLAINT BATCH 3213335 WERE TESTED USING IN HOUSE ISOLATE K. PNEUMONIAE (ENF9910). IN ADDITION, RETENTION PANELS FROM THE SAME MATERIAL (449289) BUT DIFFERENT BATCH WERE ALSO TESTED USING IN HOUSE ISOLATE K. PNEUMONIAE (ENF9910). ALL PANELS WERE LOADED INTO A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS IDENTIFIED CORRECTLY AS K. PNEUMONIAE. AS PHOENIX DOES NOT HAVE ID CLAIMS FOR P. ALCALIGENES, RETENTION PANELS FROM THE SAME MATERIAL (449289) BUT DIFFERENT BATCH NUMBER WERE TESTED USING IN HOUSE ISOLATES P. AERUGINOSA (ENF14319, ENF9516 AND A27853). ALL PANELS WERE LOADED INTO A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS IDENTIFIED CORRECTLY AS P. AERUGINOSA. AS PHOENIX DOES NOT HAVE ID CLAIMS FOR ACINETOBACTER URSINGII, RETENTION PANELS FROM THE SAME MATERIAL (449289) BUT DIFFERENT BATCH NUMBER WERE TESTED USING IN HOUSE ISOLATES OF A. BAUMANNII (ENF 15611, ENF 15612 AND ENF 15613). ALL PANELS WERE LOADED INTO A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. DURING COMPLAINT INVESTIGATION TESTING, PHOENIX REPORTED SOME OF THE RESULTS AS "UNIDENTIFIED", MORAXELLA SPP, OR OLIGELLA URETHRALIS. FOR FURTHER INVESTIGATION, R&D PERFORMED ADDITIONAL TESTING. SOME OF RESULTS WERE EITHER UNIDENTIFIED OR ACINETOBACTER SPECIES COMBO, WHICH ARE RESULTS CONSIDERED "EXPECTED" FOR A SPECIES OF ACINETOBACTER FOR WHICH PHOENIX DOES NOT HAVE ID CLAIMS. OTHER RESULTS WERE REPORTED AS A. FAECALIS, WHICH MATCHES THE ID THE CUSTOMER REPORTED. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. RETENTION PANELS OF A COMPARABLE GRAM-NEGATIVE PHOENIX PANEL WERE TESTED USING IN HOUSE ISOLATES A. JUNII (ENF 6077), KLEBSIELLA OXYTOCA (11161 AND C2263) AND C. FREUNDII (ENF9905) AND PLACED IN A PHOENIX M50 AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS IDENTIFIED CORRECTLY. RETENTION SAMPLES FROM BD INVENTORY WERE PREVIOUSLY EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO MISIDENTIFICATION OF C. BRAAKII OR E. CLOACAE, AS ALL SAMPLES MET SPECIFICATIONS. AS WE WERE ABLE TO REPRODUCE THE RESULTS THE CUSTOMER RECEIVED (MIS ID OF ACINETOBACTER URSINGII), THIS COMPLAINT IS CONFIRMED FOR ACINETOBACTER URSINGII BUT UNCONFIRMED FOR ALL OTHER GRAM-NEGATIVE ORGANISMS. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN INITIATED FOR MIS IDS OF E. COLI. THE TECHNICAL TEAM HAS IDENTIFIED A POTENTIAL ENHANCEMENT THAT WOULD BOLSTER THE INSTRUMENT¿S ABILITY TO INTERPRET THE BEHAVIOR OF E. COLI¿S INTERACTION WITH THE SUBSTRATES ON THE PANEL. BD ANTICIPATES A SOFTWARE RELEASE IN SUMMER 2024 TO ADDRESS THE PERFORMANCE ON E. COLI IDS. BD WILL COMMUNICATE ANY FURTHER UPDATES AS THEY BECOME AVAILABLE. IN ADDITION, AN OVERALL REVIEW OF GRAM-NEGATIVE PERFORMANCE IS ON-GOING AND WILL CONTINUE TO BE INVESTIGATED. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION OF THE COMPLAINT BATCHES. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PANEL PHOENIX NMIC/ID-307 A MISIDENTIFICATION WAS REPORTED FOR 14 PATIENTS. AN ISOLATE WAS COLLECTED FROM A URINE SAMPLE (ACCESSION NUMBER (B)(4). ) AND IDENTIFIED AS C. FREUNDII THEN IT WAS IDENTIFIED AS E. COLI UPON REPEAT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 14 OF 14.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PANEL PHOENIX NMIC/ID-307 A MISIDENTIFICATION WAS REPORTED FOR 14 PATIENTS. AN ISOLATE WAS COLLECTED FROM A URINE SAMPLE (ACCESSION NUMBER (B)(6) AND IDENTIFIED AS C. FREUNDII THEN IT WAS IDENTIFIED AS E. COLI UPON REPEAT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 14 OF 14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321858 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3213335 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female