MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM; SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	443624
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd phoenix¿ m50 automated microbiology system an unspecified number of patient isolates had inconsistent results.The user expected staphylococcus saprophyticus but obtained staphylococcus intermedius.No health impact or consequence reported.
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)#: k020321, k040099, k131331 and k250344.E1.Initial reporter facility name: (b)(6).Investigation summary: introduction a complaint alleges that the sample evaluation result was inconsistent.The customer was getting mis-identified results, most commonly with staphylococcus haemolyticus when expecting staphylococcus lugdunensis and staphylococcus intermedius when expecting staphylococcus saprophyticus.Material #: 443624 serial #: (b)(6).Investigational testing/ review a bd field service engineer was dispatched to the customer site.The fse noted that they were unable to simulate the results onsite.Log and binary files were sent in for further analysis and troubleshooting.Although no resolution was provided in this case, a solution was provided in a separate case where they replaced a light source board and performed several verification tests with passing results.Service history review for this instrument was completed and revealed no previous complaints related to this issue.Log files were sent in for review, but no resolution was provided.Conclusion / outcome as the resolution was provided in a separate case, this complaint is unconfirmed based on the information provided by service.The root cause cannot be determined with the information provided.Review of risk management files confirms there are no new or modified risks associated with this failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PHOENIX¿ M50 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: 25427848
• Report Number: 1119779-2026-00925
• Device Sequence Number: 16023478
• Product Code: LON
• UDI-Device Identifier: 00382904436247
• UDI-Public: (01)00382904436247
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 06/02/2026

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 Catalogue Number: 443624
• 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: 06/01/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2025
• 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