BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC-306

    MDR report key: 12028644 · Received June 18, 2021

    Report

    Report Number
    1119779-2021-01011
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 19, 2021
    Report Date
    July 18, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 10-JUN-2022. H.6. INVESTIGATION SUMMARY THIS COMPLAINT IS CONFIRMED. THIS COMPLAINT IS FOR FALSE RESISTANCE OF MEROPENEM-VABORBACTAM (MEV), CEFTAZIDIME-AVIBACTAM (CZA), AND CEFTOLOZANE-TAZOBACTAM (CT) WHEN USING PHOENIX PANEL NMIC-306 (449292) BATCH 1068393. THE CUSTOMER DID RETURN MULTIPLE ISOLATES FOR INVESTIGATION. THE CUSTOMER DID NOT RETURN PANELS OR LAB REPORTS. TO INVESTIGATE, ONE RETENTION PANEL FROM THE COMPLAINT BATCH WAS TESTED USING EACH OF THE TWENTY-THREE (23) ISOLATES RETURNED FOR INITIAL TESTING ON A PHOENIX INSTRUMENT AND EVALUATED FOR MEROPENEM-VABORBACTAM (MEV), CEFTAZIDIME-AVIBACTAM (CZA), AND CEFTOLOZANE-TAZOBACTAM (CT) MIC RESULTS. THE FOLLOWING ISOLATES PASSED INITIAL TESTING: K9205641, K919C658, K9219271, K9219275, K9174975, K9198571, K9205592, K9214442, K9219382, K9207148, K919A556, K9209285, K919B668, K921A027, AND K9218988. THE FOLLOWING ISOLATES WERE RESISTANT AND DID NOT PASS INITIAL TESTING AND REQUIRED ADDITIONAL TESTING: K9205641, K9185243, K919B862, K9177584, K917B606, K9206088, AND K918B479. ONE ADDITIONAL PANEL WAS TESTED FOR EACH OF THE FAILED ISOLATES INCLUDING A CONTROL PANEL. ALL ADDITIONALLY TESTED ISOLATES FAILED EXCEPT FOR ONE K9185243 DID PASS AS SUSCEPTIBLE FOR BOTH THE COMPLAINT BATCH AND CONTROL BATCH. ALL OTHER ISOLATES FROM THE ADDITIONALLY TESTED LIST DID FAIL AS RESISTANT INCLUDING THE CONTROL BATCH WHICH COULD INDICATE AN ISSUE WITH THE ISOLATES THEMSELVES. ALL THE FAILED ISOLATES WERE TESTED AGAIN USING RETENTION PANELS FROM THE COMPLAINT BATCH AS WELL AS A CONTROL BATCH. ONE ADDITIONAL SAMPLE PASSED WHILE THE OTHERS FAILED AS RESISTANT. K9206088 PASSED AS SUSCEPTIBLE. THIS COMPLAINT IS CONFIRMED BECAUSE THE FALSE RESISTANT RESULTS WERE REPRODUCED IN HOUSE. WE RECOMMEND REVIEWING WORKFLOW AND ALSO ENSURING THAT THE LASTED PUD VERSION IS BEING USED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED TWO ADDITIONAL COMPLAINTS FOR THE COMPLAINT BATCH NOT RELATED TO THIS SPECIFIC ISSUE. 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. PER BALTRMPHXIDASTAPH REV 10 VERSION H, ID 2.0-2.14, INDICATES THE POTENTIAL RISK OF A FALSE RESISTANT RESULT AS AN S3.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC-306 FALSE RESISTANT RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT DISCREPANT RESULTS FOR COMBO DRUGS. CUSTOMER DOES CONFIRMATION TESTING FOR CEFTAZ/AVI, MEROPENEM/VAPOR, AND CEFTOLOZANE/TAZO WITH LIOCHEMFIL GRADIENT STRIP FOR MIC COMPARISON. REPORTS HIGH MIC WITH PHOENIX AND VERY LOW MIC WITH GRADIENT STRIP FOR CARBAPENEM DRUGS THEY WILL BE RESISTANT VIA PHOENIX AND WHEN TESTED WITH KIRBY BAUER AND REPEAT TESTING WITH PHOENIX DRUGS WILL COME BACK SUSCEPTIBLE. CUSTOMER REPORTS THERE ARE NO ISSUES WITH OTHER ORGANISM TYPES SO AP CONTAMINATION IS NOT SUSPECTED AND SHE ALSO REPORTS THIS SAME ISSUE OCCURRED FOR CARBAPENEMS WITH THE NMIC300 PANEL IN THE PAST AND REQUESTS INFORMATION WHY THIS OCCURS. CUSTOMER PROBLEM: CUSTOMER REPORTS DISCREPANT ANTIBIOTIC RESULTS FOR COMBO DRUGS AND ALSO CARBAPENEMS - REPORTS OVERCALLING RESISTANCE FOR ALL OF THESE DRUG CLASSES "

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC-306 FALSE RESISTANT RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT DISCREPANT RESULTS FOR COMBO DRUGS. CUSTOMER DOES CONFIRMATION TESTING FOR CEFTAZ/AVI, MEROPENEM/VAPOR, AND CEFTOLOZANE/TAZO WITH LIOCHEMFIL GRADIENT STRIP FOR MIC COMPARISON. REPORTS HIGH MIC WITH PHOENIX AND VERY LOW MIC WITH GRADIENT STRIP FOR CARBAPENEM DRUGS THEY WILL BE RESISTANT VIA PHOENIX AND WHEN TESTED WITH KIRBY BAUER AND REPEAT TESTING WITH PHOENIX DRUGS WILL COME BACK SUSCEPTIBLE. CUSTOMER REPORTS THERE ARE NO ISSUES WITH OTHER ORGANISM TYPES SO AP CONTAMINATION IS NOT SUSPECTED AND SHE ALSO REPORTS THIS SAME ISSUE OCCURRED FOR CARBAPENEMS WITH THE NMIC300 PANEL IN THE PAST AND REQUESTS INFORMATION WHY THIS OCCURS. CUSTOMER PROBLEM: CUSTOMER REPORTS DISCREPANT ANTIBIOTIC RESULTS FOR COMBO DRUGS AND ALSO CARBAPENEMS: REPORTS OVERCALLING RESISTANCE FOR ALL OF THESE DRUG CLASSES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923075 PANEL PHOENIX NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 1068393

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown