BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-311

    MDR report key: 16653037 · Received March 30, 2023

    Report

    Report Number
    1119779-2023-00338
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 13, 2023
    Report Date
    May 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS ANOTHER LOT REPORTED TO BE INVOLVED. THE INFORMATION FOR THAT LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2256585 MEDICAL DEVICE EXPIRATION DATE: 2023-10-31 DEVICE MANUFACTURE DATE: 2022-09-13 COMMON DEVICE NAME: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY. 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

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR QC AND CLINICAL FAILURES WITH HIGH MIC RESULTS FOR ERTAPENEM (ETP), CEFTAZOLINE/TAZOBACTAN (CT) , MEROPENEM (MEM) AND CEFTAROLINE (CPT) WITH E. COLI ATCC 25922 WHEN USING PHOENIX PANEL NMIC-311 (449452) BATCH NUMBERS 2256585 AND 2305517. THE CUSTOMER DID NOT PROVIDE ISOLATES OR LAB REPORTS BUT PROVIDED PANEL RETURNS OF BOTH BATCHES FOR THE INVESTIGATION. THE CUSTOMER STATED THAT THE AP TUBING WAS NOT INSTALLED CORRECTLY, AND AFTER CORRECTLY INSTALLING THE TUBING, NO MORE INSTANCES OF FALSE RESISTANCE WERE OBSERVED. TO INVESTIGATE, FIVE (5) CUSTOMER RETURNED PANELS OF COMPLAINT BATCH 2256585 WERE INOCULATED WITH QC ISOLATE E. COLI ATCC25922 AND EVALUATED FOR MIC RESULTS. ADDITIONALLY, FIVE (5) CUSTOMER RETURNED PANELS OF COMPLAINT BATCH 2305517 WERE INOCULATED WITH QC ISOLATE E. COLI ATCC25922 AND EVALUATED FOR MIC RESULTS. ALL PANELS RETURNED THE EXPECTED SENSITIVE MIC FOR ALL ANTIMICROBIALS INCLUDING ETP, CT, MEM AND CPT, 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 BATCHES. 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. 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 THE BD PANEL PHOENIX NMIC-311 THAT THERE WAS FALSE RESISTANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER STATES FALSE RESISTANCE WITH LOT # 2256585 (PATIENTS, QC OK) AND 2305517 (QC ISSUES, NO PATIENTS RUN) FOR E. COLI. IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS:, PRODUCT: 449452, LOT # 2256585 AND 2305517. CUSTOMER STATES FALSE RESISTANCE ON PATIENT AND QC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PANEL PHOENIX NMIC-311 THAT THERE WAS FALSE RESISTANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER STATES FALSE RESISTANCE WITH LOT # 2256585 (PATIENTS, QC OK) AND 2305517 (QC ISSUES, NO PATIENTS RUN) FOR E. COLI. IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: PRODUCT: 449452 LOT # 2256585 AND 2305517. CUSTOMER STATES FALSE RESISTANCE ON PATIENT AND QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266016 BD PANEL PHOENIX NMIC-311 SEE H.10 LON BECTON, DICKINSON & CO. (SPARKS) 2305517

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown