MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ NMIC-306; SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	449292
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g4.Pma / 510(k)#: k020322, k022129, k023444, k023634, k023858, k024153, 031530, k031699, k031912, k032299, k032567, k032655, k032675, k033362, k033458, k033558, k033560, k041384, k042932, k052269, k060214, 060217, k060257, k060444, k060447, k061327, k061355, k061867, k062207, k062944, k063301, and k06348.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using the bd phoenix¿ nmic-306 a patient urine isolate (escherichia coli) had a sensitive result for the drug ceftazidime/avibactam.Conversely, the user noted that the e-test results were resistant for ceftazidime/avibactam during repeat testing.A reference laboratory was used, and the carba-r pcr result was showing the new delhi metallo-beta-lactamase (ndm) gene present.The user stated, "patient was treated with ineffective therapy (meropenem) for three days due to false susceptible result reported.".
Additional Manufacturer Narrative
Investigation summary: this complaint is for low mic results for ceftazidime/avibactam (cza) and meropenem (mem) when using panel phoenix nmic-306 (catalog number 449292) batch number 5254642.The customer returned an isolate and phoenix generated lab reports with mic results for escherichia coli for the investigation.The batch history record was satisfactory, and no quality notifications were generated during manufacturing and inspection.Complaint trending was analyzed, and no current trends were identified associated with this defect.Historical trending was reviewed and there were no trends for low mic results for panel sku 449292.To investigate, retention panels from the complaint batch were inoculated with customer returned isolate e.Coli 5892 to observe for cza and mem mic results.Next, control panels from the same material but different batch were inoculated with customer returned isolate e.Coli 5892 to observe for cza and mem mic results.The investigation returned all panels with resistant cza and susceptible mem mic and sir results for their inoculated isolates.For further investigation, disk diffusion was performed on customer returned isolate e.Coli 5892 for mem sir results.The disk diffusion shows e.Coli with resistant sir results for mem.Therefore, this complaint is confirmed for low mic mem with the customer returned isolate.As no complaint trend has been identified, no actions are indicated at this time per bd procedures.Bd will continue to monitor for trends and take action as necessary.
Event or Problem Description
It was reported while using the bd phoenix¿ nmic-306 a patient urine isolate (escherichia coli) had a sensitive result for the drug ceftazidime/avibactam.Conversely, the user noted that the e-test results were resistant for ceftazidime/avibactam during repeat testing.A reference laboratory was used, and the carba-r pcr result was showing the new delhi metallo-beta-lactamase (ndm) gene present.The user stated, "patient was treated with ineffective therapy (meropenem) for three days due to false susceptible result reported.".

• Brand Name: BD PHOENIX¿ NMIC-306
• Common Device Name: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23829341
• Report Number: 1119779-2025-05506
• Device Sequence Number: 14722611
• Product Code: LON
• UDI-Device Identifier: 30382904492923
• UDI-Public: (01)30382904492923(17)260913(10)5254642
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/13/2026
• Device Catalogue Number: 449292
• Device Lot Number: 5254642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown