BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 20321238 · Received September 27, 2024

    Report

    Report Number
    1119779-2024-00692
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 20, 2024
    Report Date
    November 4, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PHONE #: (B)(6). THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)# K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320, K181665, K033458 AND K123266. 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 WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 4128406. THE CUSTOMER DID NOT RETURN PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS, BINARY FILES AND AN ISOLATE FOR THE INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF SHIGELLA BOYDII WHEN USING THE COMPLAINT BATCH. IT IS TO BE NOTED THAT THE CUSTOMER RETURNED ISOLATE WAS MIXED AND HAD 3 COLONIES PRESENT, AND THE TESTING WAS PERFORMED ON THE LARGER COLONY. THE CUSTOMER RETURNED ISOLATE WAS VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED AS E. COLI 00156. TO INVESTIGATE, THREE RETENTION PANELS EACH FROM THE COMPLAINT BATCH WERE TESTED USING IN HOUSE ISOLATES E. COLI ENF 12571 AND E. COLI ENF 22416 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, THREE RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATE E. COLI 00156 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. LAST, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE E. COLI 00156 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATES AS E. COLI. THIS COMPLAINT IS NOT CONFIRMED. AS PART OF THE INVESTIGATION, BD R&D PERFORMED AN ANALYSIS OF THE CUSTOMER BINARY FILES. REVIEW OF THE BINARY FILES FROM THE CUSTOMER'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. 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. 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 E. COLI ISOLATE WAS MISIDENTIFIED AS S. BOYDII. 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 E. COLI ISOLATE WAS MISIDENTIFIED AS S. BOYDII. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492191 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 4128406 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown