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

Catalog Number	448803
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	06/28/2025
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-101 patient isolate results for the drugs erythromycin and clindamycin do not match the d test result nor repeat results on the device.Patient one had a sensitive clindamycin and a resistant erythromycin result.The d test result shows both clindamycin and erythromycin as resistant.No health impact or consequence reported.Report 1 of 3.
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 11-jul-2025.H3.Device eval by manufacturer- yes.Investigation summary: this complaint is for incorrect breakpoints when using phoenix panel smic-101 (catalog number 448803) batch number 5070677.The customer provided panel returns, binary files, isolate returns and phoenix generated lab reports for the investigation.The lab reports show varied mics for clindamycin (cc) and erythromycin (e) when using the complaint batch.To investigate, customer returned panels from the complaint batch were inoculated with customer returned isolate streptococcus agalactiae 4101 to observe for cc and e mic results.Also, retention panels from the complaint batch and control panels from the same material but different batch were inoculated with customer returned isolate streptococcus agalactiae 4101 to observe for cc and e mic results.The investigation returned all panels with satisfactory cc and e mic 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.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¿ smic-101 a patient isolate results for the drugs erythromycin and clindamycin do not match the d test result nor repeat results on the device.Patient one had a sensitive clindamycin and a resistant erythromycin result.The d test result shows both clindamycin and erythromycin as resistant.No health impact or consequence reported.Report 1 of 3.

• Brand Name: BD PHOENIX¿ SMIC-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: 22636456
• Report Number: 1119779-2025-02033
• Device Sequence Number: 9073878
• Product Code: LON
• UDI-Device Identifier: 30382904488032
• UDI-Public: (01)30382904488032(17)260303(10)5070677
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/04/2025

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: 03/03/2026
• Device Catalogue Number: 448803
• Device Lot Number: 5070677
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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