BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NID

    MDR report key: 13655070 · Received March 2, 2022

    Report

    Report Number
    1119779-2022-00343
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    February 11, 2022
    Report Date
    November 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LQM
    UDI-DI
    30382904480074
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 MISIDENTIFICATION OF E. COLI AS PASTEURALLA AEROGENES WHEN USING PHOENIX NID PANEL (448007) BATCH NUMBER 1053136 AND PHOENIX NMIC/ID-414 PANEL (448443) BATCH NUMBER 1153362. THE CUSTOMER DID PROVIDE PHOTOS OF LAB REPORTS, BUT DID NOT RETURN ISOLATES OR PANELS FOR INVESTIGATION. THE COMPLAINT BATCH WAS NOT AVAILABLE FOR INVESTIGATION DUE TO THE BATCH BEING EXPIRED AT THE TIME OF THE INVESTIGATION AND IS BEYOND OUR STABILITY TIMEFRAME. AS A RESULT, THIS COMPLAINT IS UNCONFIRMED FOR PERFORMANCE. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCHES. A REVIEW OF COMPLAINTS REVEALED ONE ADDITIONAL COMPLAINT ON BATCH 1053136 RELATED TO THIS ISSUE AND ONE ADDITIONAL COMPLAINT ON COMPLAINT BATCH 1153362 NOT RELATED TO THIS ISSUE. 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. PER BALTRMPHXIDASTAPH REV 10 VERSION H, ID 6.0-6.11, INDICATES THE POTENTIAL RISK OF A MIS-IDENTIFICATION WAS ASSESSED AS S4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD PHOENIX¿ NID, AN E. COLI SAMPLE WAS INCORRECTLY IDENTIFIED AS PASTEURALLA AEROGENES. CONFIRMATORY TESTING WAS PERFORMED ON THE MALDI-TOF. ERRONEOUS RESULTS WERE NOT REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN IDENTIFICATION OF PASTEURALLA AEROGENES WAS PROVIDED BY PHOENIX M50 WITH AN AGREEMENT SCORE OF 96%. THIS STRAIN WAS SENT TO ANOTHER LAB AND A MALDI-TOF RUN PROVIDE AN E. COLI IDENTIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD PHOENIX¿ NID, AN E. COLI SAMPLE WAS INCORRECTLY IDENTIFIED AS PASTEURALLA AEROGENES. CONFIRMATORY TESTING WAS PERFORMED ON THE MALDI-TOF. ERRONEOUS RESULTS WERE NOT REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN IDENTIFICATION OF PASTEURALLA AEROGENES WAS PROVIDE BY PHOENIX M50 WITH AN AGREEMENT SCORE OF 96%. THIS STRAIN WAS SENT TO ANOTHER LAB AND A MALDI-TOF RUN PROVIDE AN E. COLI IDENTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281343 BD PHOENIX¿ NID GRAM NEGATIVE IDENTIFICATION PANEL LQM BECTON, DICKINSON & CO. (SPARKS) 448007 1053136 30382904480074

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown