BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 12355285 · Received August 23, 2021

    Report

    Report Number
    1119779-2021-01420
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    August 9, 2021
    Report Date
    August 29, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS WITH ENTEROCOCCUS FAECALIS ISOLATES AND DAPTOMYCIN WHEN USING PMIC-110 (449036) BATCH NUMBER 1012545. THE CUSTOMER DID NOT PROVIDE RETURNS BUT DID PROVIDE SPECIMENS, LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. THE COMPLAINT BATCH WAS NOT AVAILABLE FOR INVESTIGATION DUE TO THE BATCH BEING EXPIRED AT THE TIME OF THE INVESTIGATION. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON EITHER OF THE COMPLAINT BATCHES. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 1012545. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BASED ON THE INVESTIGATION PERFORMED, THIS COMPLAINT IS UNABLE TO BE CONFIRMED. 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. ISOLATES MUST BE RECOVERED FROM NON-SELECTIVE MEDIA. SEE TABLE 16. RECOMMENDED MEDIA IN THE BD USER MANUAL FOR A LIST OF RECOMMENDED MEDIA. ENSURE QUALITY OF VENDOR SELECTION FOR PLATED MEDIA. VARIATIONS IN FORMULATIONS MAY IMPACT RESULTS. Ø CULTURE HANDLING: CULTURES MUST BE 18-24 HOURS OLD FOR GRAM-NEGATIVE & GRAM-POSITIVE ORGANISMS AND 18-48 HOURS OLD FOR YEAST ORGANISMS. 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: 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. ENSURE BD APPROVED NEPHELOMETER IS ADEQUATELY CALIBRATED WITH NOT EXPIRED MCFARLAND CALIBRATION TUBES. PREPARED TUBES SHOULD BE VORTEXED FOR 5 SECONDS AND ALLOWED APPROXIMATELY 10 SECONDS FOR AIR BUBBLES TO SURFACE. 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. 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. USE BACTERIAL SUSPENSIONS WITHIN 60 MINUTES OF PREPARATION. Ø PANEL PREPARATION: PANELS SHOULD BE USED WITHIN 2 HOURS OF REMOVAL FROM POUCH. INOCULATE PANELS WITHIN 30 MINUTES OF THE TIME THAT THE AST BROTH INOCULUM IS PREPARED. ALLOW SUFFICIENT TIME FOR FLUID TO TRAVERSE DOWN THE WELL TRACKS BEFORE MOVING THE PANEL. AVOID TOUCHING THE FRONT AND BACKSIDE OF THE PANEL. HANDLE PANELS BY THE SIDES TO AVOID PRODUCING SMUDGES ON THE SURFACE OF THE PANELS. 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 PANEL PHOENIX PMIC-110 3 FALSE RESISTANCES WERE OBTAINED BY THE LABORATORY PERSONNEL. AN ETEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CX IS GETTING (3) FALSE RESISTANCE ENTEROCOCCUS FAECALIS ISOLATES TO DAPTOMYCIN."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE BD PHOENIX NMIC-305 IS AN ANTIMICROBIAL RESISTANCE PANEL CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K040106, K033889, K060218, K021954, K140468, K050555, K082913, K051689, K033784, K060218, K082538, K082852, K053241, K023273, K031679, K020322, K040006, K023568, K070809, K031306, K060217, K030091, K023301, K040716, K024152, K050089, K031679, K033907, K060218, K022172, K032131, K060214, K142170, K030677, K131331, K060493.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX PMIC-110 3 FALSE RESISTANCES WERE OBTAINED BY THE LABORATORY PERSONNEL. AN ETEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CX IS GETTING (3) FALSE RESISTANCE ENTEROCOCCUS FAECALIS ISOLATES TO DAPTOMYCIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253509 BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 1012545

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown