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	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd phoenix¿ nmic-306 a patient isolate had high mics (false resistant result) for the drug ertapenem.The user noted using an e-test strip for confirmatory testing giving a susceptible result.No health impact or consequence reported.
Additional Manufacturer Narrative
E1.Initial reporter phone #: (b)(6).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 isolate had high mics (false resistant result) for the drug ertapenem.The user noted using an e-test strip for confirmatory testing giving a susceptible result.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: this complaint is for high mic ertapenem (etp) when using panel phoenix nmic-306 (catalog number 449292) batch number 5196167.The customer returned binary files, isolates and phoenix generated lab reports for the investigation.The batch history record was satisfactory, and no quality notifications were generated during manufacturing and inspection.To investigate, retention panels from the complaint batch were inoculated with customer returned isolates enterobacter cloacae complex 337343312 and klebsiella pneumoniae 3771419 to observe for etp mic results.Next, control panels from the same material but different batch were inoculated with customer returned isolates enterobacter cloacae complex 337343312 and klebsiella pneumoniae 3771419 to observe for etp mic results.The investigation returned all panels with intermediate and resistant etp mic results.For further investigation, disk diffusion was performed on customer returned isolates enterobacter cloacae complex 337343312 and klebsiella pneumoniae 3771419.The disk diffusion results show both isolates with resistance to etp.As all panels tested were either intermediate or resistant etp mic results, this complaint is unable to be confirmed.Bd does not confirm on an intermediate (i) result, as it is one dilution off from sensitive (s) or resistant (r).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.

• 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: 23404742
• Report Number: 1119779-2025-05174
• Device Sequence Number: 13023378
• Product Code: LON
• UDI-Device Identifier: 30382904492923
• UDI-Public: (01)30382904492923(17)260720(10)5196167
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/02/2026

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 Expiration Date: 07/20/2026
• Device Catalogue Number: 449292
• Device Lot Number: 5196167
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• 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