BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 12477983 · Received September 15, 2021

    Report

    Report Number
    1119779-2021-01526
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    July 1, 2021
    Report Date
    August 29, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904436247
    PMA / PMN Number
    K131331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR FAILURES DUE TO LOW MIC RESULTS FOR CEFTAZIDIME-AVIBACTAM (CZA) WHEN USING PHOENIX PANEL NMIC/ID-503 (449026) BATCH NUMBER 1082880. THE CUSTOMER PROVIDED LAB RESULT REPORTS, BUT DID NOT RETURN ISOLATES OR PANELS FOR INVESTIGATION. THE COMPLAINT BATCH WAS NOT AVAILABLE FOR INVESTIGATION DUE TO THE BATCH BEING EXPIRED AT THE TIME OF THE INVESTIGATION AND IS BEYOND OUR STABILITY TIMEFRAME. AS A RESULT, BATCH 1306571 WAS USED FOR TESTING. TO INVESTIGATE, A TOTAL OF FIVE RETENTION PANELS FROM BATCH 1306571 WERE TESTED USING A PHOENIX M50 INSTRUMENT. TWO PANELS WERE TESTED WITH QC ISOLATES OF KLEBSIELLA PNEUMONIAE (ATCC 700603) AND THREE PANELS WERE TESTED WITH QC ISOLATES OF ESCHERICHIA COLI (ATCC 25922) AND EVALUATED FOR CEFTAZIDIME-AVIBACTAM (CZA) MIC RESULTS. DURING INVESTIGATION, ALL FIVE PANELS TESTED YIELDED SATISFACTORY RESULTS IN THE EXPECTED RANGE FOR CEFTAZIDIME-AVIBACTAM (CZA). THIS COMPLAINT IS NOT CONFIRMED. 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. THE FOLLOWING ARE GUIDELINES TO HELP MINIMIZE PHOENIX AST ISSUES: Ø MEDIA SELECTION O ISOLATES MUST BE RECOVERED FROM NON-SELECTIVE MEDIA. SEE TABLE 16 RECOMMENDED MEDIA IN THE BD USER MANUAL FOR A LIST OF RECOMMENDED MEDIA. O ENSURE QUALITY OF VENDOR SELECTION FOR PLATED MEDIA. VARIATIONS IN FORMULATIONS MAY IMPACT RESULTS. Ø CULTURE HANDLING O CULTURES MUST BE 18-24 HOURS OLD FOR GRAM-NEGATIVE & GRAM-POSITIVE ORGANISMS AND 18-48 HOURS OLD FOR YEAST ORGANISMS. O FOR QC ORGANISMS, ENSURE ORGANISMS HAVE BEEN SUBCULTURED AT LEAST TWICE ON TWO CONSECUTIVE DAYS ON PROPER NONSELECTIVE MEDIA (GRAM-NEGATIVE OR GRAM-POSITIVE ORGANISMS: TSA WITH 5% SHEEP BLOOD, YEAST: SABOURAUD DEXTROSE AGAR). Ø MCFARLAND PREPARATION O USE OF A LOW-QUALITY STERILE COTTON SWAB, WHICH SHED FIBERS, COULD POTENTIALLY CONTRIBUTE TO A FALSELY HIGH MCFARLAND READING. POLYESTER SWABS ARE NOT RECOMMENDED. O ENSURE BD APPROVED NEPHELOMETER IS ADEQUATELY CALIBRATED WITH NOT EXPIRED MCFARLAND CALIBRATION TUBES. O PREPARED TUBES SHOULD BE VORTEXED FOR 5 SECONDS AND ALLOWED APPROXIMATELY 10 SECONDS FOR AIR BUBBLES TO SURFACE. O ENSURE MCFARLAND FALLS WITHIN PROPER RANGE OF THE INOCULUM DENSITY. FOR 0.5 MCFARLAND SYSTEM, 0.50-0.60 IS ACCEPTABLE. FOR 0.25 MCFARLAND SYSTEM, 0.20-0.30 IS ACCEPTABLE. FOR YEAST PANELS, 2.00-2.40 IS ACCEPTABLE. O CONFIRM CURRENT INSTRUMENT SETTINGS FOR INOCULUM DENSITY BEFORE INOCULATING PANELS. FOR EXAMPLE, ENSURE A 0.50 MCFARLAND WAS NOT PREPARED FOR A 0.25 INOCULUM DENSITY INSTRUMENT SETTING. O USE BACTERIAL SUSPENSIONS WITHIN 60 MINUTES OF PREPARATION. Ø PANEL PREPARATION O PANELS SHOULD BE USED WITHIN 2 HOURS OF REMOVAL FROM POUCH. O INOCULATE PANELS WITHIN 30 MINUTES OF THE TIME THAT THE AST BROTH INOCULUM IS PREPARED. O ALLOW SUFFICIENT TIME FOR FLUID TO TRAVERSE DOWN THE WELL TRACKS BEFORE MOVING THE PANEL. O AVOID TOUCHING THE FRONT AND BACKSIDE OF THE PANEL. HANDLE PANELS BY THE SIDES TO AVOID PRODUCING SMUDGES ON THE SURFACE OF THE PANELS. O INOCULATED PANELS SHOULD BE HANDLED WITH CARE. AVOID KNOCKING OR JARRING THE PANEL. LOAD PANELS INTO INSTRUMENT WITHIN 30 MINUTES OF INOCULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FALSE RESISTANCE TO CEFTAZIDIME/AVIBACTAM WAS PRODUCED ON THE BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "CUSTOMER REPORTS HIGH RATE OF FALSE RESISTANCE TO CEFTAZIDIME/AVIBACTAM."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. 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 FALSE RESISTANCE TO CEFTAZIDIME/AVIBACTAM WAS PRODUCED ON THE BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "CUSTOMER REPORTS HIGH RATE OF FALSE RESISTANCE TO CEFTAZIDIME/AVIBACTAM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375283 BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEM LON BECTON, DICKINSON & CO. (SPARKS) 443624 NA 00382904436247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown