BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX NMIC-304

    MDR report key: 11333244 · Received February 16, 2021

    Report

    Report Number
    1119779-2021-00305
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    January 26, 2021
    Report Date
    March 4, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904484867
    PMA / PMN Number
    K032299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FOR FALSE RESISTANT CARBAPENEM RESULTS WHEN USING PHOENIX PANEL NMIC 304 (448486) BATCHES 0210495, 0245325 AND 0282502. THE CUSTOMER PROVIDED LAB REPORT RESULTS, BINARY FILES AND ISOLATE RETURNS FOR INVESTIGATION. FIVE RETENTION PANELS FROM A SEPARATE BATCH OF THIS PANEL TYPE NMIC 304 (448486) WERE USED TO TEST EACH OF THE FIVE ISOLATES PROVIDED BY THE CUSTOMER. ERTAPENEM (ETP) WAS TESTED WITH ESCHERICHIA COLI 1598M. IMIPENEM (IPM) WAS TESTED WITH ESCHERICHIA COLI 0168M. IMIPENEM (IPM) WAS TESTED WITH ESCHERICHIA COLI 108M. ERTAPENEM (ETP) WAS TESTED WITH PROTEUS MIRABILIS 2348M. ERTAPENEM (ETP) WAS TESTED WITH ESCHERICHIA COLI 0013M. THE FIVE PANELS YIELDED SENSITIVE RESULTS PER THE PACKAGE INSERT. TWO RETENTION PANELS FROM COMPLAINT BATCH 0282502 WERE USED TO TEST ERTAPENEM (ETP) USING CLINICAL ISOLATE ESCHERICHIA COLI 1598M, WHERE BOTH YIELDED SENSITIVE RESULTS PER THE PACKAGE INSERT. TWO RETENTION PANELS FROM COMPLAINT BATCH 0245325 WERE USED TO TEST ERTAPENEM (ETP) USING CLINICAL ISOLATE ESCHERICHIA COLI 0013M, WHERE BOTH YIELDED SENSITIVE RESULTS PER THE PACKAGE INSERT. EIGHT RETENTION PANELS FROM COMPLAINT BATCH 0210495 WERE USED. IMIPENEM (IPM) WAS TESTED WITH ESCHERICHIA COLI 0168M. IMIPENEM (IPM) WAS TESTED WITH ESCHERICHIA COLI 108M. ERTAPENEM (ETP) WAS TESTED WITH PROTEUS MIRABILIS 2348M. ERTAPENEM (ETP) WAS TESTED WITH ESCHERICHIA COLI 0013M. ALL PANELS YIELDED SENSITIVE RESULTS PER THE PACKAGE INSERT. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON ANY OF THE THREE COMPLAINT BATCHES. A REVIEW OF COMPLAINTS REVEALED NO COMPLAINTS GENERATED ON ANY OF THE THREE COMPLAINT BATCHES. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED FOR THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS DEFECT AND TAKE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH BD PHOENIX¿ NMIC-304 THERE WAS FALSE RESISTANCE.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0210495. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2020-07-28. MEDICAL DEVICE LOT #: 0245325. MEDICAL DEVICE EXPIRATION DATE: 2021-09-30. DEVICE MANUFACTURE DATE: 2020-09-01. MEDICAL DEVICE LOT #: 0282502. MEDICAL DEVICE EXPIRATION DATE: 2021-10-31. DEVICE MANUFACTURE DATE: 2020-10-08. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TESTING WITH BD PHOENIX¿ NMIC-304 THERE WAS FALSE RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231282 BD PHOENIX NMIC-304 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT LON BECTON, DICKINSON & CO. (SPARKS) 448486 SEE H.10 30382904484867

    Patients

    Seq Age Sex Outcome Treatment
    1