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

Catalog Number	448100
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
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)#: k020321, k020322, k020323, k040099, and k131331.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¿ automated microbiology system a patient isolate had abnormal antimicrobial susceptibility results.No further information was provided.No health impact or consequence reported.
Additional Manufacturer Narrative
Additional information was provided by the customer indicating that no patient results were affected.This complaint is not mdr reportable.There was no report of serious injury, medical intervention, or reportable device malfunction.The previous mfr report #1119779-2025-04923 should be considered cancelled.

• Brand Name: BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
• 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: 22964613
• Report Number: 1119779-2025-04923
• Device Sequence Number: 18419314
• Product Code: LON
• UDI-Device Identifier: 00382904481001
• UDI-Public: (01)00382904481001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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 Catalogue Number: 448100
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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