BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC-311

    MDR report key: 11952159 · Received June 7, 2021

    Report

    Report Number
    1119779-2021-00949
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 2, 2021
    Report Date
    March 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS COMPLAINT IS FOR FALSE RESISTANCE OF IMIPENEM (IPM) AND MEROPENEM (MEM) WITH PSEUDOMONAS AERUGINOSA WHEN USING PHOENIX PANEL NMIC-311 (449452) BATCH NUMBER 0210157. THE CUSTOMER DID RETURN LAB REPORTS, HOWEVER DID NOT RETURN ISOLATES OR PANELS FOR INVESTIGATION. TO INVESTIGATE, A TOTAL OF TEN PANELS OF THE SAME PANEL TYPE AS THE COMPLAINT BATCH WAS TESTED USING TWO DIFFERENT ISOLATES OF PSEUDOMONAS AERUGINOSA AND EVALUATED FOR IMIPENEM (IPM) AND MEROPENEM (MEM) RESULTS ON A PHOENIX M50 INSTRUMENT. THE TWO PSEUDOMONAS AERUGINOSA ISOLATES USED WERE QC ISOLATE A27853 AND IN HOUSE ISOLATE ENF18981 AND FIVE PANELS WERE TESTED WITH EACH ISOLATE. ALL PANELS TESTED YIELDED SATISFACTORY RESULTS FOR BOTH IMIPENEM (IPM) AND MEROPENEM (MEM). THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THE COMPLAINT BATCHES.   A REVIEW OF COMPLAINTS REVEALED NO 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

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC-311 FALSE RESISTANCE WAS OBSERVED BY THE LABORATORY PERSONNEL. A REFERENCE LAB WAS USED TO CONFIRM THE RESULTS AS FALSE RESISTANCE. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THERE WAS A FALSE CRE. ¿ STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: PHARMACY RAN SOME REPORTS AND THOUGHT THEY WERE SEEING FALSE CRE RESULTS. FOLLOWED UP WITH THE CUSTOMER. 1 ISOLATE WAS DETERMINED TO BE FALSE RESISTANT. ISOLATES WERE REPORTED OUT AS POSSIBLE CRE, AND SENT TO THE STATE LAB. CUSTOMER JUST SENT OUT A SECOND ISOLATE, BUT IT HAS NOT BEEN CONFIRMED YET. CUSTOMER ALSO HAD A P. AERUG THAT WAS SUSCEPTIBLE TO ALL DRUGS, BUT RESISTANT TO CARBAPENEMS. STATE LAB CONFIRMED THE RESULT THOUGH. CUSTOMER TO FAX IN LAB REPORT. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX (B)(4) FALSE RESISTANCE WAS OBSERVED BY THE LABORATORY PERSONNEL. A REFERENCE LAB WAS USED TO CONFIRM THE RESULTS AS FALSE RESISTANCE. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THERE WAS A FALSE CRE. ¿ STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: PHARMACY RAN SOME REPORTS AND THOUGHT THEY WERE SEEING FALSE CRE RESULTS. FOLLOWED UP WITH THE CUSTOMER. 1 ISOLATE WAS DETERMINED TO BE FALSE RESISTANT. ISOLATES WERE REPORTED OUT AS POSSIBLE CRE, AND SENT TO THE STATE LAB. CUSTOMER JUST SENT OUT A SECOND ISOLATE, BUT IT HAS NOT BEEN CONFIRMED YET. CUSTOMER ALSO HAD A P. AERUG THAT WAS SUSCEPTIBLE TO ALL DRUGS, BUT RESISTANT TO CARBAPENEMS. STATE LAB CONFIRMED THE RESULT THOUGH. CUSTOMER TO FAX IN LAB REPORT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846146 PANEL PHOENIX NMIC-311 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 0210157

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown