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	11/06/2025
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 blood isolate (escherichia coli) had a resistant result for the drugs ceftazidime/avibactam and ertapenem while the drug meropenem was sensitive.Conversely, the user noted that the e-test results were sensitive for ceftazidime/avibactam and ertapenem during repeat testing.A reference laboratory was used giving sensitive results and the carba-r pcr result showing all carbapenemases "not detected." the user stated, "the patient was treated with unnecessary broad-spectrum antibiotics (cefiderocol and eravacycline) due to false resistant ceftazidime and avibactam result reported.".
Additional Manufacturer Narrative
Investigation summary: this complaint is for high mic results for ceftazidime/avibactam (cza) and carbapenems 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 reviewed, and no current trends were identified associated with this defect.Historical trending was reviewed and there were no trends for high mic results for panel sku 449292.To investigate, retention panels from the complaint batch were inoculated with customer returned isolate e.Coli (b)(6) to observe for cza, ertapenem and meropenem mic results.Next, control panels from the same material but different batch were inoculated with customer returned isolate e.Coli (b)(6) to observe for cza, ertapenem and meropenem mic results.The investigation returned all panels with susceptible cza and meropenem mic and sir results for their inoculated isolates, and intermediate ertapenem mic and sir results.Bd does not confirm on an intermediate (i) result, as it is one dilution off from sensitive (s) or resistant (r).Therefore, this complaint is unable to be confirmed.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.Please continue to communicate any additional concerns.
Event or Problem Description
It was reported while using the bd phoenix¿ nmic-306 a patient blood isolate (escherichia coli) had a resistant result for the drugs ceftazidime/avibactam and ertapenem while the drug meropenem was sensitive.Conversely, the user noted that the e-test results were sensitive for ceftazidime/avibactam and ertapenem during repeat testing.A reference laboratory was used giving sensitive results and the carba-r pcr result showing all carbapenemases "not detected.".The user stated, "the patient was treated with unnecessary broad-spectrum antibiotics (cefiderocol and eravacycline) due to false resistant ceftazidime and avibactam 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: 23828894
• Report Number: 1119779-2025-05502
• Device Sequence Number: 15769981
• 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): 02/23/2026

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: 11/20/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/25/2026
• 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