BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 16585329 · Received March 21, 2023

    Report

    Report Number
    1119779-2023-00317
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    February 22, 2023
    Report Date
    May 16, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    K181665
    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

    THERE WERE WAS ANOTHER LOT NUMBER REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT#: 2022-10-12. MEDICAL DEVICE EXPIRATION DATE: 2023-10-03. DEVICE MANUFACTURE DATE: 2285390. COMMON DEVICE NAME: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY. INITIAL REPORTER ADDR 1: (B)(6). 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 FALSE NEGATIVE ESBL AND CPO RESULTS FOR K. PNEUMONIAE AND E. COLI WHEN USING PHOENIX PANEL NMIC/ID-307 (449289) BATCH NUMBERS 2285390 AND 2291573. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS AND ISOLATES BUT PROVIDED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW PATIENT SAMPLES OF K. PNEUMONIAE. TO INVESTIGATE, ONE (1) RETENTION PANEL FROM COMPLAINT BATCH 2285390 WERE TESTED WITH QC ISOLATE E. COLI A25922 FOR ESBL RESULTS. IN ADDITION, ONE (1) RETENTION PANEL FROM COMPLAINT BATCH 2285390 WERE TESTED WITH QC ISOLATE K. PNEUMONIAE A700603 FOR ESBL RESULTS. NEXT, ONE (1) RETENTION PANEL FROM COMPLAINT BATCH 2291573 WERE TESTED WITH QC ISOLATE K. PNEUMONIAE A700603 FOR ESBL RESULTS. LAST, ONE (1) RETENTION PANEL FROM COMPLAINT BATCH 2291573 WERE TESTED WITH QC ISOLATE E. COLI A25922 FOR ESBL RESULTS. ALL FOUR (4) PANELS RETURNED SATISFACTORY RESULTS, THE TWO (2) PANELS WITH K. PNEUMONIAE A700603 FLAGGED AS ESBL POSITIVE, THE TWO (2) PANELS WITH E. COLI A25922 DID NOT FLAG AS ESBL POSITIVE. AS A RESULT, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCHES. A REVIEW OF COMPLAINTS REVEALED ONE (1) ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 2285390, AND TWO (2) ADDITIONAL COMPLAINTS ON BATCH 2291573, 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. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. THE FOLLOWING ARE GUIDELINES TO HELP MINIMIZE PHOENIX AST ISSUES: 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. 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). 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. 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 THE PANEL PHOENIX NMIC/ID-307 THAT THERE WAS FALSE NEGATIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DID ERRONEOUS RESULTS OCCUR? YES. IF YES, DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): RESULTS WERE NOT REPORTED IN ERROR. RESULTS WERE REVIEWED AND REPEATED BEFORE THE RESULTS WERE RELEASED. DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? N/A. IF YES, DETAILED HAZARD INCLUDING ANY MEDICAL INTERVENTION: N/A. CUSTOMER PROBLEM: RESISTANCE MARKERS NOT FLAGGING. CUSTOMER LOCATION (COUNTRY): US. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER HAD 2 ISOLATES (E. COLI AND P. MIRABILIS) THAT THEY BELIEVES SHOULD HAVE BEEN FLAGGED AS ESBL DUE TO RESISTANCE, AND ONE P. AERUGINOSA THEY BELIEVED SHOULD HAVE BEEN FLAGGED FOR CPO. CUSTOMER HAS NOT PERFORMED CONFIRMATORY TESTING. CUSTOMER TO FAX LAB REPORTS. REQUESTED ISOLATES. CUSTOMER CANNOT SAVE BINARY FILES. LOTS: 2285390 AND 2291573 AFFECTED. RESOLUTION ACHIEVED (Y/N)? : N. QUANTITY RECEIVED AND QUANTITY AFFECTED: AMOUNT RECEIVED NOT PROVIDED. AMOUNT AFFECTED: 3 PANELS AFFECTED. WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? PATIENT. NO RESISTANCE MARKERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE PANEL PHOENIX NMIC/ID-307 THAT THERE WAS FALSE NEGATIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DID ERRONEOUS RESULTS OCCUR? YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): RESULTS WERE NOT REPORTED IN ERROR. RESULTS WERE REVIEWED AND REPEATED BEFORE THE RESULTS WERE RELEASED. DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? N/A. IF YES¿DETAILED HAZARD INCLUDING ANY MEDICAL INTERVENTION: N/A. CUSTOMER PROBLEM: RESISTANCE MARKERS NOT FLAGGING. CUSTOMER LOCATION (COUNTRY): US. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER HAD 2 ISOLATES (E. COLI AND P. MIRABILIS) THAT THEY BELIEVES SHOULD HAVE BEEN FLAGGED AS ESBL DUE TO RESISTANCE, AND ONE P. AERUGINOSA THEY BELIEVED SHOULD HAVE BEEN FLAGGED FOR CPO. CUSTOMER HAS NOT PERFORMED CONFIRMATORY TESTING. CUSTOMER TO FAX LAB REPORTS. REQUESTED ISOLATES. CUSTOMER CANNOT SAVE BINARY FILES. LOTS 2285390 AND 2291573 AFFECTED. RESOLUTION ACHIEVED (Y/N)? : N. QUANTITY RECEIVED AND QUANTITY AFFECTED: AMOUNT RECEIVED NOT PROVIDED. AMOUNT AFFECTED: 3 PANELS AFFECTED. WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? PATIENT. NO RESISTANCE MARKERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366286 PANEL PHOENIX NMIC/ID-307 SEE H.10 LON BECTON, DICKINSON & CO. (SPARKS) 449289 2291573 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown