BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AP AST INDICATOR SOLUTION

    MDR report key: 13545931 · Received February 16, 2022

    Report

    Report Number
    1119779-2022-00249
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    January 24, 2022
    Report Date
    October 14, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382902460061
    PMA / PMN Number
    K020321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0300775, MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, DEVICE MANUFACTURE DATE: 2020-10-26; MEDICAL DEVICE LOT #: 1097548, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2021-04-07. 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 FOR PANEL ABORTS WHEN USING BAG PHOENIX AP AST INDICATOR (246006) BATCHES 0300775 AND 1097548. THE CUSTOMER DID NOT PROVIDED PHOTOS OR RETURNS FOR THE INVESTIGATION. FOR INVESTIGATION, FOUR (4) RETENTION BOTTLES OF AP AST INDICATOR FROM THE COMPLAINT BATCH 0300775 WERE DROPPED INTO 20 AST BROTH TUBES (5 TUBES PER INDICATOR BOTTLE) AND THEN POURED INTO TWENTY (20) INTERNAL QC PANELS. THE TWENTY (20) QC PANELS WERE RAN ON A M50 INSTRUMENT TO OBSERVE FOR TEST ABORTS. AT THE END OF THE RUN, THERE WERE NO TEST ABORTS OBSERVED DUE TO INSUFFICIENT INDICATOR. THREE (3) RETENTION BOTTLES FROM THE COMPLAINT BATCH 1097548 WERE USED TO TEST 12 AST BROTHS, AND 12 INTERNAL QC PANELS. THESE PANELS WERE LOADED INTO A PHOENIX INSTRUMENT TO OBSERVE FOR ANY TEST ABORTS AT THE END OF THE RUN. AT THE END OF THE RUN, THERE WAS ONE PANEL THAT TEST ABORTED DUE TO INSUFFICIENT INDICATOR.A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH 0300775 OR 1097548. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 0300775. A REVIEW OF COMPLAINTS REVEALED TWO ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 1097548. BASED ON THE INVESTIGATION PERFORMED, THIS COMPLAINT IN UNABLE TO BE CONFIRMED FOR BATCH 0300775 BUT IS CONFIRMED FOR BATCH 1097548. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THE COMPLAINT DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PHOENIX¿ AP AST INDICATOR SOLUTION THERE WAS A PERFORMANCE ISSUE - ATYPICAL GROWTH, ATYPICAL REACTION, FAILURE TO INHIBIT, INSUFFICIENT GROWTH, POTENCY, PH FAILURE FOR PREPARED REAGENTS/MEDIA THAT COULD IMPACT GROWTH PERFORMANCE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE RECENTLY STARTED USING A NEW INDICATOR LOT ON (B)(6) 2022 (LOT: 1145474, EXP: 30/6/22) AND NOTED THAT QC FOR GENTAMICIN ON E.COLI ATCC (B)(4) HAS PASSED THIS WHOLE WEEK. HOWEVER, WE HAVE CONTINUED TO PERFORM CONCURRENT DISC TESTING FOR GENTAMICIN AND NOTED THAT THERE ARE STILL DISCREPANCIES IN INTERPRETATION DESPITE QC PASSING."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PHOENIX¿ AP AST INDICATOR SOLUTION THERE WAS A PERFORMANCE ISSUE - ATYPICAL GROWTH, ATYPICAL REACTION, FAILURE TO INHIBIT, INSUFFICIENT GROWTH, POTENCY, PH FAILURE FOR PREPARED REAGENTS/MEDIA THAT COULD IMPACT GROWTH PERFORMANCE.THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE RECENTLY STARTED USING A NEW INDICATOR LOT ON 14/01/22 (LOT: 1145474, EXP: 30/6/22) AND NOTED THAT QC FOR GENTAMICIN ON E.COLI ATCC 25922 HAS PASSED THIS WHOLE WEEK. HOWEVER, WE HAVE CONTINUED TO PERFORM CONCURRENT DISC TESTING FOR GENTAMICIN AND NOTED THAT THERE ARE STILL DISCREPANCIES IN INTERPRETATION DESPITE QC PASSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390295 BD PHOENIX¿ AP AST INDICATOR SOLUTION SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 246006 SEE H.10 30382902460061

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown