MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ NMIC-311; SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	449452
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd phoenix¿ nmic-311 the user noted that there was an increase in extended-spectrum beta-lactamase (esbl) and carbapenem resistant isolates.Additionally, the user noted qc failures associated with high mics.No health impact or consequence reported.Report 5 of 8.
Additional Manufacturer Narrative
B3.Date of event is unknown.The date received by manufacturer has been used for this field.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, k033362, k033458, k033560, k041384, k042932, k052269, k060214, k060217, k060257, k060444, k060447, k061327, k061355, k062207, k062944, k063301, k063486, k063573, k063811, and k06382.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: this complaint is for false positive esbl results when using phoenix panel nmic-311 (catalog number 449452) batch number 5127465.Customer returned panels, isolates or phoenix generated lab reports were not available for the investigation.It is to be noted that the nmic-311 does not include cpo detect.To investigate, retention panels of the complaint batch and control panels of the same material but different batch number were inoculated with in house isolate escherichia coli a25922 and placed in a phoenix m50 to observe for esbl flags.All panels returned the isolate with esbl negative results; therefore, 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.Please continue to communicate any additional concerns.
Event or Problem Description
It was reported while using the bd phoenix¿ nmic-311 the user noted that there was an increase in extended-spectrum beta-lactamase (esbl) and carbapenem resistant isolates.Additionally, the user noted qc failures associated with high mics.No health impact or consequence reported.Report 5 of 8.

• Brand Name: BD PHOENIX¿ NMIC-311
• 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: 22739617
• Report Number: 1119779-2025-02557
• Device Sequence Number: 7189015
• Product Code: LON
• UDI-Device Identifier: 30382904494521
• UDI-Public: (01)30382904494521(10)5127465
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/26/2025

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: 05/09/2026
• Device Catalogue Number: 449452
• Device Lot Number: 5127465
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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