BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 21667836 · Received March 21, 2025

    Report

    Report Number
    1119779-2025-00208
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    December 21, 2024
    Report Date
    April 29, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS SHIGELLA BOYDII AND SHIGELLA DYSENTERIAE WHEN USING PHOENIX PANEL NMIC/ID-(B)(6) (CATALOG NUMBER 449289) BATCH NUMBER 4121483. THE CUSTOMER DID NOT RETURN PANELS BUT PROVIDED ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF S. BOYDII AND S. DYSENTERIAE WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES E. COLI CV-1 AND E. COLI CV-2 ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING QC ISOLATE E. COLI (B)(6) ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. LAST, CONTROL PANELS OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES E. COLI CV-1 AND E. COLI CV-2 ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED WITH CUSTOMER RETURNED AND QC ISOLATES E. COLI CV-2 AND E. COLI (B)(6) RETURNED E. COLI IDENTIFICATION RESULTS. THE PANELS TESTED WITH CUSTOMER RETURNED ISOLATE E. COLI CV-1 IDENTIFIED THE ISOLATE AS SHIGELLA BOYDII. THIS COMPLAINT IS CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PHONE #: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-(B)(6)A PATIENT ISOLATE (ESCHERICHIA COLI) WAS MISIDENTIFIED AS SHIGELLA BOYDII AND THEN SHIGELLA DYSENTERIAE UPON REPEAT. THE RESULT WAS VERIFIED WITH A REFERENCE LABORATORY. 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 (ESCHERICHIA COLI) WAS MISIDENTIFIED AS SHIGELLA BOYDII AND THEN SHIGELLA DYSENTERIAE UPON REPEAT. THE RESULT WAS VERIFIED WITH A REFERENCE LABORATORY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424420 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4121483 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown