BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-306

    MDR report key: 12594001 · Received October 7, 2021

    Report

    Report Number
    1119779-2021-01619
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 10, 2021
    Report Date
    January 20, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR DISCREPANT CPO DETECTION OF PSEUDOMONAS AERUGINOSA WHEN USING PHOENIX PANEL NMIC-306 (449292) BATCH NUMBER 1153359. THE CUSTOMER DID RETURN ISOLATES FOR INVESTIGATION, HOWEVER NO LAB REPORTS OR PANELS WERE RETURNED. TO INVESTIGATE, A TOTAL OF EIGHT RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED ON A PHOENIX M50 INSTRUMENT. THE RETENTION PANELS WERE TESTED USING THE FOLLOWING QC ISOLATES: ENF18981 (PSEUDOMONAS AERUGINOSA), ENF18982 (PSEUDOMONAS AERUGINOSA), AND A25922 (ESCHERICHIA COLI). ONE CUSTOMER RETURNED ISOLATE, 75575 (PSEUDOMONAS AERUGINOSA) WAS TESTED IN ADDITION TO THE QC ISOLATE. TWO PANELS WERE TESTED PER ISOLATE AND EVALUATED FOR AMBLER CLASSIFICATION RESULTS. DURING INVESTIGATION, ALL PANELS TESTED USING ISOLATES A25922 AND CUSTOMER RETURNED 75575 DID NOT CLASSIFY AS CLASS B CARBAPENEMASE PRODUCERS. ALL PANELS TESTED USING ISOLATES ENF18981 AND ENF18982 DID CLASSIFY AS CLASS B CARBAPENEMASE PRODUCERS AS EXPECTED. THIS COMPLAINT IS NOT CONFIRMED. IN ADDITION TO THE QUALITY INVESTIGATION PERFORMED, R&D INVESTIGATED USING THE CUSTOMER RETURNED ISOLATES ASSOCIATED WITH THIS PR AND PR 3800931. INTERNAL R&D TESTING DID NOT CONFIRM CPO FALSE POSITIVE OR CLASS B FALSE POSITIVE RESULTS FOR 2 OUT OF 2 ISOLATES. SERRATIA MARCESCENS YIELDED SUSCEPTIBLE MICS TO IPM, MEM, ETP, CZA AND CT ON BMD. PSEUDOMONAS AERUGINOSA YIELDED RESISTANT MICS TO IPM AND MEM, WHILE YIELDING SUSCEPTIBLE RESULTS FOR CZA AND CT ON BMD. PSEUDOMONAS AERUGINOSA HAS INTRINSIC RESISTANCE TO ETP. ALTHOUGH ALL CARBAPENEM MICROBIALS ARE RESISTANT FOR PSEUDOMONAS AERUGINOSA, IT HAS THE POTENTIAL TO BE A CARBAPENEMASE PRODUCING ORGANISM BUT CANNOT BE CONFIRMED WITHOUT PCR TESTING. HOWEVER, IT IS UNLIKELY THAT BOTH STRAINS ARE CARBAPENEMASE PRODUCING ORGANISMS SINCE MCIM WAS NEGATIVE. FURTHERMORE, BOTH ISOLATES PRODUCED RESISTANCE TO 3RD GENERATION CEPHALOSPORINS (CAZ AND CRO) AND ATM, WHICH SUGGESTS OTHER RESISTANCE MECHANISMS SUCH AS AMP C BETA-LACTAMASE PRODUCTION AND/OR REDUCED PORIN EXPRESSION.   CLOXACILLIN (CLX) IS A CLASS C BETA-LACTAMASE INHIBITOR AND IS ADDED IN COMBINATION WITH MEM ON THE CPO DETECT TEST TO REDUCE BACKGROUND BETA-LACTAMASE ACTIVITY THAT CAN CONFOUND THE PANEL. IT CAN BE CONCLUDED THAT THE CPO DETECT TEST ON NMIC-306 AND NMIC-307 PANEL PRODUCED FALSE CPO POSITIVE RESULTS, BECAUSE MEM61D (MEM+CLX) WELL DID NOT EFFECTIVELY INHIBIT AMP C PRODUCTION IN THE STRAINS. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THE COMPLAINT BATCH.   A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS FOR 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. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS AND WE APOLOGIZE FOR THE DELAY IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE BD PANEL PHOENIX NMIC-306 IS AN ANTIMICROBIAL RESISTANCE PANEL CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K061327,K031912, K023444, K063824, K033560, K063573,K041384, K060217, K052269, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K190905, K032655, K062944, K060444, K173252, K033362, K062207, K063811, K163637, K151320, K063301, K031530, K060447,K032567, K060257, K023634, K020322, K132674, K173523, K063486, K022129, K023858, K071623, K031699, K060447, K024153, K060214, K132909, K042932 H.3. 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 USING PANEL PHOENIX NMIC-306 THERE WAS A DISCREPANCY IN CPO DETECTION OF 2 ISOLATES OF PSEUDOMONAS AERUGINOSA WITH USE OF NMIC 306 PANELS. BOTH PANELS WERE REPEATED, AND SENT OFF TO STATE LAB, WHO PERFORMED MCIM AND DID NOT DETECT ANY CARBAPENEMASES FROM EITHER ISOLATE. THEY THEN PERFORMED CRE PCR USING SENSITITRE GNX2F ASSAY, WHICH WAS VALIDATED BY THE CDC AND DCLS, AND DID NOT DETECT ANY RESISTANCE MARKERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DISCREPANCY IN CPO DETECTION OF 2 ISOLATES OF PSEUDOMONAS AERUGINOSA WITH USE OF NMIC 306 PANELS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC-306 THERE WAS A DISCREPANCY IN CPO DETECTION OF 2 ISOLATES OF PSEUDOMONAS AERUGINOSA WITH USE OF NMIC 306 PANELS. BOTH PANELS WERE REPEATED, AND SENT OFF TO STATE LAB, WHO PERFORMED MCIM AND DID NOT DETECT ANY CARBAPENEMASES FROM EITHER ISOLATE. THEY THEN PERFORMED CRE PCR USING SENSITITRE GNX2F ASSAY, WHICH WAS VALIDATED BY THE CDC AND DCLS, AND DID NOT DETECT ANY RESISTANCE MARKERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DISCREPANCY IN CPO DETECTION OF 2 ISOLATES OF PSEUDOMONAS AERUGINOSA WITH USE OF NMIC 306 PANELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492057 BD PANEL PHOENIX NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 1153359

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown