BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 13097109 · Received December 28, 2021

    Report

    Report Number
    1119779-2021-02053
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 3, 2021
    Report Date
    September 9, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    SEE H10
    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

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF PATIENT SAMPLES WHICH GREW LACTOSE FERMENTING ORGANISMS BUT RESULTED AS SHIGELLA AND PSEUDOMONAS WHEN USING PHOENIX PANEL NMIC/ID-307 (449289) BATCH NUMBER 1251384. THE CUSTOMER DID NOT RETURN LAB REPORTS OR PANELS FOR INVESTIGATION. THE CUSTOMER DID PROVIDE ISOLATE RETURNS, HOWEVER THEY WERE RETURNED UNDER A DIFFERENT PR NUMBER AND WERE NOT PURE, AND COULD NOT BE USED FOR THIS INVESTIGATION. TO INVESTIGATE, A TOTAL OF SIX RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED ON A PHOENIX M50 INSTRUMENT. THREE PANELS WERE TESTED USING QC ISOLATES OF ESCHERICHIA COLI (ATCC (B)(4)) AND THREE PANELS TESTED USING QC ISOLATES OF PSEUDOMONAS AERUGINOSA (ATCC (B)(4)), AND EVALUATED FOR IDENTIFICATION RESULTS. DURING INVESTIGATION, ALL PANELS IDENTIFIED CORRECTLY. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED TWO ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Additional Manufacturer Narrative · 0

    PMA / 510(K)#: THE BD PHOENIX NMIC-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K032655, K062944, K060444, K063811, K151320, K063301, K031530, K060447, K023634, K020322, K132674, K023858, K071623, K031699, K060447, K024153, K060214, K042932. 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 THAT WHILE TESTING WITH THE PANEL PHOENIX NMIC/ID-307, TWO QUESTIONABLE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT URINE SPECIMENS, GREW LACTOSE FERMENTING ORGANISMS AND WERE RESULTED AS SHIGELLA AND PSEUDOMONAS

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE PANEL PHOENIX NMIC/ID-307, TWO QUESTIONABLE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT URINE SPECIMENS, GREW LACTOSE FERMENTING ORGANISMS AND WERE RESULTED AS SHIGELLA AND PSEUDOMONAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993887 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 449289 1251384 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown