BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 18257544 · Received December 4, 2023

    Report

    Report Number
    1119779-2023-01304
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    October 1, 2023
    Report Date
    April 2, 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

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ACINETOBACTER URSINGII AS ALCALIGENES FAECALIS WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 3103003. THE CUSTOMER DID NOT RETURN ISOLATES OR PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOWED A SAMPLE IDENTIFIED AS A. FAECALIS WHEN USING THE COMPLAINT BATCH. BATCH 3213003 WAS UNAVAILABLE FOR INVESTIGATION TESTING AND A COMPARABLE PANEL OF THE SAME MATERIAL WAS USED INSTEAD. IT IS TO BE NOTED THAT PHOENIX ID SYSTEMS DO NOT HAVE CLAIMS FOR A. URSINGII. THEREFORE, IN HOUSE ISOLATES OF ACINETOBACTER BAUMANNII WERE USED FOR INVESTIGATION TESTING. THE THREE IN HOUSE ISOLATES WERE VERIFIED AS A. BAUMANNII (ENF 15611, ENF 15612 AND ENF 15613) ON A BRUKER MALDI BIOTYPER. TO INVESTIGATE, TWO PANELS EACH FROM THE COMPARABLE BATCH WERE TESTED USING IN HOUSE ISOLATES A. BAUMANNII (ENF 15611, ENF 15612 AND ENF 15613) ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ADDITIONALLY, ONE PANEL EACH FROM A CONTROL BATCH OF THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATES A. BAUMANNII (ENF 15611, ENF 15612 AND ENF 15613) ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS IDENTIFIED THE ISOLATES AS MORAXELLA SPP. THE THREE CONTROL PANELS OF THE SAME MATERIAL BUT DIFFERENT BATCH RESULTED IN A. BAUMANNII, OLIGELLA URETHRALIS, AND NO-ID. THIS COMPLAINT IS CONFIRMED FOR MISIDENTIFICATION. AS PART OF THE INVESTIGATION, BD R&D PERFORMED AN ANALYSIS/COMPARISON BETWEEN THE BD TESTING LAB REPORTS AND THE CUSTOMER LAB REPORTS. REVIEW OF THE LAB REPORTS FROM BD¿S INTERNAL TESTING SHOWS VARIABILITY IN SOME OF THE SUBSTRATE REACTIONS. 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. REVIEW OF THE FILES SHOWS THAT SOME OF THE SUBSTRATE REACTIONS WERE MORE ALIGNED WITH A MORAXELLA SPP. IDENTIFICATION AS OPPOSED TO A. BAUMANNII. HOWEVER, BASED ON THE ANALYSIS, THERE WERE NO RESULTS THAT STOOD OUT TO BE A DEFINITIVE CAUSE OF THE MIS IDS. 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. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: D4. MEDICAL DEVICE LOT #: 3213003. D4. MEDICAL DEVICE EXPIRATION DATE: 25-JUL-2024. H4. DEVICE MANUFACTURE DATE: 01-AUG-2023.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307 ACINETOBACTER URSINGII MISIDENTIFIED AS ALCALIGENES FAECALIS. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307 ACINETOBACTER URSINGII MISIDENTIFIED AS ALCALIGENES FAECALIS. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307 ACINETOBACTER URSINGII MISIDENTIFIED AS ALCALIGENES FAECALIS. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399856 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3213003 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown