BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AST-S INDICATOR SOLUTION

    MDR report key: 12591609 · Received October 7, 2021

    Report

    Report Number
    1119779-2021-01616
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 9, 2021
    Report Date
    September 6, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382902460092
    PMA / PMN Number
    K050745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR PANEL ABORTS DUE TO INSUFFICIENT INDICATOR WHEN USING PHOENIX AST-S INDICATOR ((B)(4). ) BATCH 1088556. THE CUSTOMER DID NOT PROVIDE RETURNS, PHOTOS OR LAB REPORTS FOR THE INVESTIGATION. THE COMPLAINT BATCH 1088556 WAS NOT AVAILABLE FOR INVESTIGATION DUE TO THE BATCH BEING EXPIRED AT THE TIME OF THE INVESTIGATION AND IS BEYOND OUR STABILITY TIMEFRAME. 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 BATCH. BASED ON THE INVESTIGATION PERFORMED, THIS COMPLAINT IS UNABLE TO BE CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD PHOENIX¿ AST-S INDICATOR SOLUTION THERE WERE MANY FAILURES IN SMIC GALLERIES. CONFIRMATORY TESTING WAS DONE USING AGAR PLATES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE HAVE HAD MANY FAILURES OF OUR SMIC GALLERIES. I INCRIMINATED THE REAGENT REF (B)(4). HAVING A NEW BATCH WE DID OUR ANTIBIOTIC SUSCEPTIBILITY TESTS WITH IT AND NO MORE FAILURES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: 1088556 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD PHOENIX¿ AST-S INDICATOR SOLUTION THERE WERE MANY FAILURES IN SMIC GALLERIES. CONFIRMATORY TESTING WAS DONE USING AGAR PLATES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE HAVE HAD MANY FAILURES OF OUR SMIC GALLERIES. I INCRIMINATED THE REAGENT REF 246009. HAVING A NEW BATCH WE DID OUR ANTIBIOTIC SUSCEPTIBILITY TESTS WITH IT AND NO MORE FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486020 BD PHOENIX¿ AST-S INDICATOR SOLUTION SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 246009 SEE H10 30382902460092

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown