MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ SMIC/ID-101; SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	448802
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	12/21/2025
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)#k032675, k050745, k050747, k050780, k050865, k050881, k050946, k050982, k051109, k051138, k051204, k051266, k051272, k051692, and k062206.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¿ smic/id-101 a patient isolate (streptococcus pneumoniae) had incorrect mic results for the drug trimethoprim/sulfamethoxazole (tmp/smx).The user compared the results to an older panel and kirby bauer testing, receiving discrepant results.No health impact or consequence reported.This is report 2 of 4.
Additional Manufacturer Narrative
Investigation summary: this complaint is for incorrect breakpoints with trimethoprim-sulfamethoxazole (sxt) with streptococcus pneumoniae when using phoenix panel smic/id-101 (catalog number 448802) batch number 5014275.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 performed, and no trends were identified associated with this defect.As no trends were identified, no corrective actions are slated at this time.To investigate, retention panels of the complaint batch and control panels were inoculated with in house isolates s.Pneumoniae a49619 and s.Pneumoniae 3992 and placed in a phoenix m50 to observe for sxt mic results.All panels returned the isolate results with the expected resistant (for s.Pneumoniae 3992) and susceptible (for s.Pneumoniae a49619) sxt mic and sir 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 bd phoenix¿ smic/id-101 a patient isolate (streptococcus pneumoniae) had incorrect mic results for the drug trimethoprim/sulfamethoxazole (tmp/smx).The user compared the results to an older panel and kirby bauer testing, receiving discrepant results.No health impact or consequence reported.This is report 2 of 4.

• Brand Name: BD PHOENIX¿ SMIC/ID-101
• 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: 24394227
• Report Number: 1119779-2026-00230
• Device Sequence Number: 15598473
• Product Code: LON
• UDI-Device Identifier: 30382904488025
• UDI-Public: (01)30382904488025(17)260113(10)5014275
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 04/14/2026

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: 01/13/2026
• Device Catalogue Number: 448802
• Device Lot Number: 5014275
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2025
• 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