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

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	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd phoenix panel nmic-306, a patient sample gave a false resistant result.There was no report of patient impact.
Additional Manufacturer Narrative
G5.Multiple 510k: 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.Investigation summary: this complaint is for high mic ertapenem (etp) with klebsiella pneumoniae and escherichia coli when using phoenix panel nmic-306 (catalog number 449292) batch number 4044887.The customer returned isolates but did not return panels but provided phoenix generated lab reports and isolates for the investigation.To investigate, retention panels of the complaint batch were inoculated with customer returned isolates k.Pneumoniae hccl-1, e.Coli hccl-2, and k.Pneumoniae hccl-3 and placed a phoenix m50 machine to evaluate for etp mic results.Also, control panels from the same material but different batch were inoculated with customer returned isolates k.Pneumoniae hccl-1, e.Coli hccl-2, and k.Pneumoniae hccl-3 and placed a phoenix m50 machine to evaluate for etp mic results.All panels tested returned the expected mic results for etp with their respective isolates.This complaint is not confirmed.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.Bd will continue to monitor for trends and take action as necessary.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.

• Brand Name: BD PHOENIX PANEL NMIC-306
• Common Device Name: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY
• 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: 22938667
• Report Number: 1119779-2025-04802
• Device Sequence Number: 18615233
• Product Code: LON
• UDI-Device Identifier: 00382904492922
• UDI-Public: (01)00382904492922(11)240213(17)250207(10)4044887
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• 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
• Report Date (Section B): 07/10/2025

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: 02/07/2025
• Device Catalogue Number: 449292
• Device Lot Number: 4044887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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