BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 14380449 · Received May 12, 2022

    Report

    Report Number
    1119779-2022-00687
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 30, 2022
    Report Date
    September 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    K151320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR VARIOUS AST FAILURES WHEN USING PHOENIX PANEL NMIC-306 (449292) BATCH NUMBER 1208760. THE CUSTOMER DID PROVIDE PANEL, BROTH AND ISOLATE RETURNS FOR INVESTIGATION. TO INVESTIGATE, THE FOLLOWING PANELS FROM BATCH 1208760 WERE TESTED ON AN M50 INSTRUMENT USING QC ISOLATES: THREE PANELS WERE TESTED WITH KLEBSIELLA PNEUMONIAE (14780) AND THE FOLLOWING DRUGS: ERTAPENEM (ETP) AND MEROPENEM (MEM). ALL RESULTS MET THE EXPECTED RESULTS. THREE PANELS WERE TESTED WITH ESCHERICHIA COLI (ATCC 25922) AND THE FOLLOWING DRUGS: ERTAPENEM (ETP) AND MEROPENEM (MEM). ALL RESULTS MET THE EXPECTED RESULTS. ADDITIONALLY, TWO CONTROL PANELS FROM A DIFFERENT BATCH WERE TESTED WITH ESCHERICHIA COLI (ATCC 25922) AND THE FOLLOWING DRUGS: ERTAPENEM (ETP) AND MEROPENEM (MEM). ALL RESULTS MET THE EXPECTED RESULTS. TO INVESTIGATE, THE FOLLOWING PANELS FROM BATCH 1208760 WERE TESTED ON AN M50 INSTRUMENT USING CUSTOMER RETURNED ISOLATES: ONE PANEL WAS TESTED WITH CITROBACTER KOSERI AND ERTAPENEM (ETP), AND MET THE EXPECTED RESULTS. ONE PANEL WAS TESTED WITH CITROBACTER KOSERI AND MEROPENEM (MEM), AND MET THE EXPECTED RESULTS. ONE PANEL WAS TESTED WITH SAMPLE #1 OF ESCHERICHIA COLI AND ERTAPENEM (ETP), AND MET THE EXPECTED RESULTS. ONE PANEL WAS TESTED WITH SAMPLE #1 OF ESCHERICHIA COLI AND MEROPENEM (MEM), AND MET THE EXPECTED RESULTS. ONE PANEL WAS TESTED WITH SAMPLE #2 OF ESCHERICHIA COLI AND ERTAPENEM (ETP), AND MET THE EXPECTED RESULTS. ONE PANEL WAS TESTED WITH SAMPLE #2 OF ESCHERICHIA COLI AND MEROPENEM (MEM), AND MET THE EXPECTED RESULTS. ONE PANEL WAS TESTED WITH KLEBSIELLA PNEUMONIAE AND ERTAPENEM (ETP), AND MET THE EXPECTED RESULTS. ONE PANEL WAS TESTED WITH KLEBSIELLA PNEUMONIAE AND MEROPENEM (MEM), AND MET THE EXPECTED RESULTS. THREE PANELS WERE TESTED WITH MORGANELLA MORGANII AND ERTAPENEM (ETP), AND MET THE EXPECTED RESULTS. THREE PANELS WERE TESTED WITH MORGANELLA MORGANII AND MEROPENEM (MEM), AND MET THE EXPECTED RESULTS. DURING INVESTIGATION, ALL PANELS IDENTIFIED CORRECTLY. BASED OFF THE RESULTS, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED TWO QUALITY NOTIFICATIONS FOR THIS COMPLAINT BATCH, BUT NOT RELATED TO THIS DEFECT. A REVIEW OF COMPLAINTS REVEALED ONE ADDITIONAL COMPLAINT FOR THIS COMPLAINT BATCH, NOT RELATED TO THIS DEFECT. 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 WHILE USING BD PHOENIX PANEL NMIC-306 FALSE RESISTANCE WHICH HAS BEEN OBSERVED WITH BOTH ERTAPENEM AND MEROPENEM. THERE HAS BEEN 5 OCCURRENCES REPORTED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER CUSTOMER IS REPORTING FALSE RESISTANCE WHICH HAS BEEN OBSERVED WITH BOTH ERTAPENEM AND MEROPENEM. LOT NUMBER - 1208760.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX PANEL NMIC-306 FALSE RESISTANCE WHICH HAS BEEN OBSERVED WITH BOTH ERTAPENEM AND MEROPENEM. THERE HAS BEEN 5 OCCURRENCES REPORTED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER CUSTOMER IS REPORTING FALSE RESISTANCE WHICH HAS BEEN OBSERVED WITH BOTH ERTAPENEM AND MEROPENEM. LOT NUMBER - 1208760.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789656 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 1208760

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown