BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 20663347 · Received November 12, 2024

    Report

    Report Number
    1119779-2024-00822
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 11, 2024
    Report Date
    January 31, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    K181665
    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

    E1. INITIAL REPORTER PHONE #: (B)(6). 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 OF ESCHERICHIA COLI AS SHIGELLA BOYDII WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 4191751. THE CUSTOMER DID NOT RETURN PANELS BUT PROVIDED AN ISOLATE, BINARY FILES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW AN ISOLATE IDENTIFIED AS E. COLI WHEN USING THE COMPLAINT BATCH WITH SPECIAL MESSAGE "BASED ON THE INSTRUMENT ID PRODUCED, SEROLOGICAL CONFIRMATION RECOMMENDED". THE CUSTOMER RETURNED ISOLATE WAS VERIFIED AND LABELED AS E. COLI S-2 WITH A BRUKER MALDI BIOTYPER. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH AND ONE CONTROL PANEL WERE TESTED USING CUSTOMER RETURNED ISOLATE E. COLI S-2 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED IDENTIFIED THE ISOLATE AS S. BOYDII, THEREFORE, THIS COMPLAINT IS CONFIRMED FOR MISIDENTIFICATION. AS PART OF THE INVESTIGATION, BD R&D PERFORMED AN ANALYSIS OF THE BD TESTING LAB REPORTS AND BINARY FILES. REVIEW OF THE LAB REPORTS FROM BD¿S INTERNAL TESTING SHOWS VARIABILITY IN SOME OF THE SUBSTRATE REACTIONS. REVIEW OF THE FILES SHOWS THAT SOME OF THE SUBSTRATE REACTIONS WERE MORE ALIGNED WITH A S. BOYDII IDENTIFICATION AS OPPOSED TO E. COLI. HOWEVER, BASED ON THE ANALYSIS, THERE WERE NO RESULTS THAT STOOD OUT TO BE A DEFINITIVE CAUSE OF THE MIS IDS. FURTHER EVALUATION OF THE CUSTOMER RETURNED ISOLATE SHOWED THAT THE ISOLATE IS A SHIGA TOXIN-PRODUCING ESCHERICHIA COLI (STEC). THE DIFFICULTY IN DIFFERENTIATING BETWEEN SHIGELLA SPECIES AND ESCHERICHIA COLI, BOTH CLOSELY-RELATED MEMBERS OF THE ENTEROBACTERALES GROUP, IS WIDELY KNOWN. ALTHOUGH THESE SPECIES ARE PHENOTYPICALLY VERY SIMILAR, THEY ARE EPIDEMIOLOGICALLY DIFFERENT IN THEIR PRESENTATION OF CLINICAL DISEASE. BECAUSE OF THIS, MANY CLINICAL LABORATORIES WILL INCORPORATE GUIDANCE IN THEIR STANDARD OPERATING PROCEDURES FOR RULING OUT MISIDENTIFICATION OF SHIGELLA SPECIES AND E. COLI BY COMMON IDENTIFICATION SYSTEMS BY CHECKING COLONY MORPHOLOGY AND INDOLE AND MOTILITY REACTIONS. IF, AFTER ASSESSMENT OF ALL AVAILABLE INFORMATION, A CLINICAL LAB IS UNABLE TO CONFIDENTLY REPORT AN IDENTIFICATION BETWEEN THESE TWO SPECIES, THE ISOLATE MAY BE SENT TO A REFERENCE LABORATORY FOR DEFINITIVE IDENTIFICATION. 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. AS NO TRENDS WERE IDENTIFIED, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE, E. COLI, WAS MISIDENTIFIED AS SHIGELLA BOYDII. THE USER NOTED THAT THE ISOLATE WAS BETA-HEMOLYTIC, OXIDASE-NEGATIVE, INDOLE-POSITIVE, LACTOSE-FERMENTING AND A GRAM-NEGATIVE ROD. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE, E. COLI, WAS MISIDENTIFIED AS SHIGELLA BOYDII. THE USER NOTED THAT THE ISOLATE WAS BETA-HEMOLYTIC, OXIDASE-NEGATIVE, INDOLE-POSITIVE, LACTOSE-FERMENTING AND A GRAM-NEGATIVE ROD. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236896 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 4191751 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown