MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ PID; GRAM POSITIVE IDENTIFICATION PANEL

Catalog Number	448008
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	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).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¿ pid, a patient isolate (staphylococcus epidermidis) was misidentified as staphylococcus aureus, or staphylococcus saprophyticus.The user verified the final result by performing repeat testing using a reference laboratory.No health impact or consequence reported.This is report 3 of 12.
Additional Manufacturer Narrative
Investigation summary: this complaint is for misidentification when using phoenix panel pid (catalog number 448008) batch number 5114581.The customer returned phoenix generated lab reports showing staphylococcus aureus and staphylococcus epidermidis identifications 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.Bd will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.To investigate, panels of the complaint batch and control panels from the same material but different batch were tested using in house isolate s.Epidermidis pos 3644 on a phoenix m50 machine and evaluated for identification results.The panels tested identified their inoculated isolates correctly, this complaint is not confirmed.
Event or Problem Description
It was reported while using the bd phoenix¿ pid a patient isolate (staphylococcus epidermidis) was misidentified as staphylococcus aureus or staphylococcus saprophyticus.The user verified the final result by performing repeat testing using a reference laboratory.No health impact or consequence reported.This is report 3 of 12.

• Brand Name: BD PHOENIX¿ PID
• Common Device Name: GRAM POSITIVE IDENTIFICATION PANEL
• 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: 24402229
• Report Number: 1119779-2026-00240
• Device Sequence Number: 8269825
• Product Code: LQL
• UDI-Device Identifier: 00382904480080
• UDI-Public: (01)00382904480080(17)260420(10)5114581
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: NA
• 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): 03/18/2026

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: 04/20/2026
• Device Catalogue Number: 448008
• Device Lot Number: 5114581
• 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: 03/03/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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