BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 18246220 · Received December 1, 2023

    Report

    Report Number
    1119779-2023-01295
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 4, 2023
    Report Date
    January 31, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492892
    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

    G5. PMA / 510(K)#: THE PANEL PHOENIX NMIC/ID-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320 H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H3 OTHER TEXT : NA.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE AS KLEBSIELLA OZAENAE AND ESCHERICHIA COLI AS ENTEROBACTER CLOACAE WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 3213335. THE CUSTOMER DID NOT RETURN ISOLATES OR PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW A PATIENT ISOLATE IDENTIFIED AS K. PNEUMONIAE AS K. OZAENAE AND E. COLI AS E. CLOACAE ON THE COMPLAINT BATCH. TO INVESTIGATE, THREE RETENTION PANELS EACH FROM COMPLAINT BATCH 3213335 WERE TESTED USING IN HOUSE ISOLATE K. PNEUMONIAE ENF9910 AND E. COLI ENF9924 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, TWO CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATE K. PNEUMONIAE ENF9910 AND E. COLI ENF9924 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE TEN PANELS TESTED IDENTIFIED THEIR RESPECTIVE ISOLATE CORRECTLY, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. WHILE THERE HAS BEEN AN OBSERVATION OF A PERFORMANCE FAILURE BY THE CUSTOMER, BD HAS NOT BEEN ABLE TO REPLICATE THE FAILURE THROUGH INVESTIGATIVE TESTING. AN OVERALL REVIEW OF GRAM-NEGATIVE PERFORMANCE IS ON-GOING AND WILL CONTINUE TO BE INVESTIGATED. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED TEN ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 3213335, RELATED TO THIS DEFECT AND UNCONFIRMED AND ALL FROM THE SAME CUSTOMER. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT.

    Description of Event or Problem · 0

    1 OF 2 IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307, THERE WAS A MISIDENTIFICATION. THERE WAS NO REPORT OF PATIENT IMPACT. PATIENT # 2: ID AS ENTEROBACTER CLOACAE. FINAL ID REPORTED: PATIENT # 2 = E. COLI (ISOLATE WAS INDOLE POS).

    Description of Event or Problem · 0

    1 OF 2 IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307, THERE WAS A MISIDENTIFICATION. THERE WAS NO REPORT OF PATIENT IMPACT. PATIENT # 2: ID AS ENTEROBACTER CLOACAE FINAL ID REPORTED: PATIENT # 2 = E. COLI (ISOLATE WAS INDOLE POS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400157 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 3213335 00382904492892

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown