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	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd phoenix¿ nmic-306, the drug amoxicillin and clavulanate was reported as intermediate when the user expected the result to be resistant for a patient isolate.It is to be noted that based on current software release intermediate is the expected result.No health impact or consequence reported.
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, k031530, 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 the drug amoxicillin and clavulanate was reported as intermediate when the user expected the result to be resistant for a patient isolate.It is to be noted that based on current software release intermediate is the expected result.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: this complaint is for qc failures due to low mic results for amoxicillin-clavulanate (amc) with klebsiella oxytoca when using phoenix panel nmic-306 (catalog number 449292) batch number 5295702.Customer returned phoenix generated lab reports were provided for the investigation.The lab reports show intermediate results with amc when using the complaint batch.The batch history record was satisfactory, and no quality notifications were generated during manufacturing and inspection.Complaint trending was performed, and no trends were identified associated with this defect.As no trends were identified, no corrective actions are slated at this time.Bd will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.To investigate, retention panels from the complaint batch and control panels were inoculated with in house isolate k.Oxytoca 11161 to observe for amc mic results.The investigation returned all panels with satisfactory resistant mic results for amc; therefore, this complaint is not confirmed.

• 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: 24293017
• Report Number: 1119779-2026-00116
• Device Sequence Number: 9388440
• Product Code: LON
• UDI-Device Identifier: 30382904492923
• UDI-Public: (01)30382904492923(17)261026(10)5295702
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 03/02/2026

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 Catalogue Number: 449292
• Device Lot Number: 5295702
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2025
• 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