BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 17209630 · Received June 27, 2023

    Report

    Report Number
    1119779-2023-00715
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 26, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904436247
    PMA / PMN Number
    K131331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIAGTION SUMMARY THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS ENTEROBACTER CLOACAE AND PROTEUS MIRABILIS AS PROVIDENCIA RETTGERI WHEN USING PHOENIX PANEL NMIC/ID-307 (449289) BATCH NUMBER 3087678. THE CUSTOMER RETURNED ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW ID TEST RESULTS FROM PHOENIX AND MALDI IDENTIFYING ESCHERICHIA COLI AS ENTEROBACTER CLOACAE AND PROTEUS MIRABILIS AS PROVIDENCIA RETTGERI. THE FIVE CUSTOMER RETURNED ISOLATES WERE TESTED ON A BRUKER MALDI AND VERIFIED TWO ISOLATES AS E. COLI AND THREE ISOLATES AS P. MIRABILIS. TO INVESTIGATE, ONE RETENTION PANEL FROM THE COMPLAINT BATCH AND ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WAS TESTED USING CUSTOMER RETURNED ISOLATE E. COLI 799981 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, ONE RETENTION PANEL FROM THE COMPLAINT BATCH AND ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WAS TESTED USING CUSTOMER RETURNED ISOLATE E. COLI 808088-1 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALSO, ONE RETENTION PANEL FROM THE COMPLAINT BATCH AND ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WAS TESTED USING CUSTOMER RETURNED ISOLATE P. MIRABILIS 806619 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THEN, ONE RETENTION PANEL FROM THE COMPLAINT BATCH AND ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WAS TESTED USING CUSTOMER RETURNED ISOLATE P. MIRABILIS 807654 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. LAST, ONE RETENTION PANEL FROM THE COMPLAINT BATCH AND ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WAS TESTED USING CUSTOMER RETURNED ISOLATE P. MIRABILIS 808088-2 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. FOR A TOTAL OF TEN PANELS. ALL TEN PANELS RETURNED THE CORRECT IDENTIFICATION RESULTS, 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 COMPLAINT 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. BD ENCOURAGES YOU TO CONSIDER THE FOLLOWING PARAMETERS TO OPTIMIZE RESULTS WITHIN YOUR LABORATORY. QC TESTING SHOULD ONLY BE PERFORMED ON 2ND PASS SUBCULTURES AND AVOID USING COLONIES THAT HAVE BEEN SUB-CULTURED MULTIPLE TIMES ISOLATED COLONIES ARE TO BE USED FOR INOCULATION AND CAREFULLY CHECK PURITY PLATES TO ENSURE THE INOCULUM CONSISTED OF ONE ISOLATE TYPE OPTIMUM PERFORMANCE COMES FROM USING FRESH 18-24 HOUR, WELL-ISOLATED COLONIES ENSURE PROPER, SUFFICIENT INOCULUM DENSITY ALLOW BUBBLES TO DISSIPATE AFTER VORTEXING PROPERLY CALIBRATE THE BD PHOENIXSPEC¿ NEPHELOMETER WITH IN-DATE MCFARLAND CALIBRATION STANDARDS USE SWABS WITH MINIMAL FIBER SHED MAKE THE PROPER INOCULUM DENSITY FOR THE INOCULUM SYSTEM SETTING (I.E., IF PREPARING A 0.25 MCFARLAND INOCULUM, ENSURE THAT THE SYSTEM IS SET TO 0.5 INOCULUM MODE) VOLUME OF ID BROTH SHOULD BE VISUALLY ASSESSED FOR ANY OBVIOUS LOW FILLS ENSURE PROPER INCUBATION TEMPERATURE AND ENVIRONMENT USE THE CORRECT MEDIA TYPE AS LISTED AS ACCEPTABLE FOR USE IN THE USER¿S MANUAL (NOTE - IT IS HELPFUL TO DISCLOSE THE MEDIA TYPE AND VENDOR WHEN PROVIDING THE DETAILS OF THE COMPLAINT) HANDLE PANELS BY ONLY TOUCHING THE SIDES; TOUCHING THE FRONT OR BACK OF THE PANELS MAY CAUSE INTERFERENCE IN THE READINGS AND LEAD TO ERRORS FOLLOW USER¿S MANUAL INSTRUCTIONS FOR TIME LIMITS ON POURING INOCULATED ID BROTH INTO THE PANEL AND PLACING THE PANEL INTO THE INSTRUMENT; EXTENDED PERIODS OF TIME OUTSIDE OF THE STATED LIMITATIONS MAY YIELD ERRORS THANK YOU AGAIN FOR CONTACTING BD AND PLEASE CONTINUE TO COMMUNICATE ANY FURTHER CONCERNS.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. E.1. INITIAL REPORTER PHONE #: ALTERNATE NUMBER PROVIDED: (B)(6).. H3. 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 · 0

    REPORT 3 OF 5 IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM, FALSE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6): ISOLATE 2 PROTEUS MIRABILIS MISIDENTIFIED AS MORGANELLA MORGANII.

    Description of Event or Problem · 0

    REPORT 3 OF 5 IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM, ISOLATE 2 PROTEUS MIRABILIS MISIDENTIFIED AS PROVIDENCIA RETTGERI. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLEASE PROVIDE THE FOLLOWING LOT NUMBERS AND STORAGE CONDITIONS, PANEL: NMIC/ID 307 3087678 (ROOM TEMP), PHOENIX ID BROTH: 3067435 (ROOM TEMP), PHOENIX AP BROTH LOT: 2244352 (ROOM TEMP, INSTRUMENT), AST BROTH/AST-S BROTH: 2299810 (ROOM TEMP, COVERED FROM LIGHT), 4.5ML AST BROTH (IF APPLICABLE): 3068148 (ROOM TEMP, COVERED FROM LIGHT), AST INDICATOR/AST-S INDICATOR: N/A, PHOENIX AST INDICATOR: 3032487 (ROOM TEMP, INSTRUMENT), WHAT IS THE OPEN DATE ON YOUR INDICATOR? OPEN 6/6, HOW OLD ARE THE ORGANISMS UPON PREPARATION OF INOCULUM? 18-24 HOURS, PLEASE PROVIDE THE MANUFACTURER AND TYPE OF MEDIA CULTURES ARE BEING SET UP FROM? BBL WAS CULTURE PURITY CONFIRMED?: YES. WHAT IS THE SOURCE OF CULTURE(S) FOR THE ORGANISMS YOU HAVE HAD ISSUES WITH AND WILL BE SENDING?: URINE, RESPIRATORY. HOW MANY ISOLATES WILL YOU BE SENDING FOR INVESTIGATION AND WHAT ARE THE IDS (THIS INFORMATION IS NEEDED TO REQUEST BIOHAZARD SHIPPERS)? 5 ISOLATES: 808088: ISOLATE 2 PROTEUS MIRABILIS MISIDENTIFIED AS PROVIDENCIA RETTGERI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929763 BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 443624 00382904436247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown