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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
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 k031530 k031699 k031912 k032299 k032567 k032655 k033362 k033560 k041384 k042932 k052269 k060214 k060217 k060257 k060444 k060447 k061327 k061355 k062207 k062944 k063301 k063486 k063573 k063811 k063824 k071623 k123404 k132674 k132909 k151320 k173252 k190905 k163637 k173523 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 bd phoenix¿ nmic-311 that an unspecified number of patient isolates had an increase in extended-spectrum beta-lactamases (esbl) resistance.The user noted that upon repeat the resistant isolates were sensitive.No health impact or consequence reported.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information: d10.Device available for eval- yes.D10.Returned to manufacturer on 05-feb-2025.H3.Device eval by manufacturer- yes.Investigation summary: this complaint is for false positive esbl results when using phoenix panel nmic-311 (catalog number 449452) batch number 4310170.The customer did not provide isolates but provided phoenix generated lab reports, panel returns and binary files for the investigation.Retention samples of complaint batch 4310170 was unavailable for testing and a comparable batch was used.To investigate, customer returned panels of the complaint batch were tested with in house isolate escherichia coli enf 12749 (esbl positive) on a phoenix m50 and evaluated for esbl results.Next, retention panels of the comparable batch and control panels from the same material but different batch were tested using qc and in house isolates escherichia coli a25922 (esbl negative) and escherichia coli enf 12749 on a phoenix m50 machine and evaluated for esbl results.The panels tested identified their inoculated isolates with the correct esbl flags, this complaint is not confirmed.A review of the binary files was determined not to be required based on the results of the investigation.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.
Event or Problem Description
It was reported while using the bd phoenix¿ nmic-311 that an unspecified number of patient isolates had an increase in extended-spectrum beta-lactamases (esbl) resistance.The user noted that upon repeat the resistant isolates were sensitive.No health impact or consequence reported.

• 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: 21399376
• Report Number: 1119779-2025-00074
• Device Sequence Number: 21211979
• Product Code: LON
• UDI-Device Identifier: 30382904494521
• UDI-Public: (01)30382904494521(11)241105(17)251101(10)4310170
• 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): 05/27/2025

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: 11/01/2025
• Device Catalogue Number: 449452
• Device Lot Number: 4310170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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