BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AP

    MDR report key: 12262444 · Received August 2, 2021

    Report

    Report Number
    1119779-2021-01262
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    July 4, 2021
    Report Date
    June 30, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR FAILURES DUE TO HIGH MIC RESULTS WITH CEFTAZIDIME-AVIBACTAM (CZA) AND CEFTAZIDIME (CAZ) WHEN USING PHOENIX PANEL NMIC-311 (449452) BATCH 1110129. THE CUSTOMER RETURNED LAB REPORTS, HOWEVER DID NOT PROVIDE RETURNED ISOLATES OR PANELS FOR INVESTIGATION. TO INVESTIGATE, TWO RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING QC ISOLATES OF ESCHERICHIA COLI (A25922, ENF19112, AND ENF 19106) FOR A TOTAL OF SIX PANELS ON A PHOENIX INSTRUMENT AND EVALUATED FOR CEFTAZIDIME-AVIBACTAM (CZA) AND CEFTAZIDIME (CAZ) MIC RESULTS. DURING INVESTIGATION, ALL PANELS TESTED YIELDED A SATISFACTORY MIC RESULT FOR CEFTAZIDIME-AVIBACTAM (CZA) AND CEFTAZIDIME (CAZ), THEREFORE THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. 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. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. PER BALTRMPHXIDASTAPH REV 10 VERSION H, ID 2.0-2.14, INDICATES THE POTENTIAL RISK OF A FALSE RESISTANT RESULT AS AN S3. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AP ATYPICAL RESULTS WERE OBTAINED. THERE IS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " WE ARE GETTING A RESULT FOR ENTEROBACTERIALES OF CEFTAZIDIME / AVIBACTAM RESISTANT AND CEFTOLOZANE/ TAZOBACTAM RESISTANT YET CEFTAZIDIME=SENSITIVE. THIS SEEMS HIGHLY UNLIKELY BUT I CAN NOT FIND ANY LITERATURE CONFIRMING WHETHER THIS CAN HAPPEN OR SHOULD NOT HAPPEN."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AP ATYPICAL RESULTS WERE OBTAINED. THERE IS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE GETTING A RESULT FOR ENTEROBACTERIALES OF CEFTAZIDIME / AVIBACTAM RESISTANT AND CEFTOLOZANE/ TAZOBACTAM RESISTANT YET CEFTAZIDIME=SENSITIVE. THIS SEEMS HIGHLY UNLIKELY BUT I CAN NOT FIND ANY LITERATURE CONFIRMING WHETHER THIS CAN HAPPEN OR SHOULD NOT HAPPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155349 BD PHOENIX¿ AP NEPHELOMETER, FOR CLINICAL USE JQX BECTON, DICKINSON & CO. (SPARKS) 1110129

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown