MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ NMIC/ID-307; SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	449289
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	11/15/2025
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)#: g4.Pma / 510(k)# k020322, k023444, k023634, k023858, k024153, k031530, k031699, k032299, k032655, k033560, k041384, k042932, k052269, k060214, k060217, k060444, k060447, k061355, k062944, k063301, k063573, k063811, k063824, k071623, k132674, k151320, k181665, k033458 and k123266.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 panel phoenix nmic/id-307 an unspecified number of patient isolates (escherichia coli) had a high mic (false resistant) result for the drug ertapenem.The user verified the final result using e-test strip.The user also noted the failure for qc results.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: this complaint is for high mic results for ertapenem (etp) when using panel phoenix nmic/id-307 (catalog number 449289) batch number 5266662.Customer returned panels, isolates or phoenix generated lab reports were not available 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 high mic results for panel sku 449289.To investigate, retention panels from the complaint batch were inoculated with qc isolate escherichia coli a25922 to observe for etp mic results.Next, control panels from the same material but different batch were inoculated with qc isolate escherichia coli a25922 to observe for etp mic results.The investigation returned all panels with satisfactory susceptible etp sir and mic results, therefore this complaint is not confirmed.Bd will continue to monitor for trends and take action as necessary.
Event or Problem Description
It was reported while using the panel phoenix nmic/id-307 an unspecified number of patient isolates (escherichia coli) had a high mic (false resistant) result for the drug ertapenem.The user verified the final result using e-test strip.The user also noted the failure for qc results.No health impact or consequence reported.

• Brand Name: BD PHOENIX¿ NMIC/ID-307
• 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: 23830480
• Report Number: 1119779-2025-05508
• Device Sequence Number: 5093900
• Product Code: LON
• UDI-Device Identifier: 30382904492893
• UDI-Public: (01)30382904492893(17)260919(10)5266662
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/20/2026

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: 09/19/2026
• Device Catalogue Number: 449289
• Device Lot Number: 5266662
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• 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