MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ PMIC/ID-106; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	448606
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	08/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.7 initial reporter addr 1: (b)(6).Investigation summary: this complaint is not confirmed.This complaint is for false negative mrsa flags with when using phoenix panel pmic/id-106 (448606) batch number 3038364.The customer did not provide phoenix generated lab reports but provided an isolate and panels for investigation.To investigate, one customer returned panel of batch 3038364 was inoculated with customer returned isolate s.Aureus and placed in a phoenix m50 to observe for mrsa flags.Next, five retention panels of complaint batch 3038364 was inoculated with customer returned isolate s.Aureus and placed in a phoenix m50 to observe for mrsa flags.Last, two control panels from the same material but different batch was inoculated with customer returned isolate s.Aureus and placed in a phoenix m50 to observe for mrsa flags.All eight panels returned the isolate with rule 1542 (mrsa) flags, therefore, this complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batches.A review of complaints revealed three additional complaints on the complaint batch, not related to this defect.Complaint trending was performed, and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.
Event or Problem Description
It was reported while using bd phoenix¿ pmic/id-106, there was a false susceptible result.There was no report of patient impact.

• Brand Name: BD PHOENIX¿ PMIC/ID-106
• 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: 22585583
• Report Number: 1119779-2025-01896
• Device Sequence Number: 4565255
• Product Code: LON
• UDI-Device Identifier: 30382904486069
• UDI-Public: (01)30382904486069(11)230207(17)240130(10)3038364
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K021954
• 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
• Report Date (Section B): 06/11/2025

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: 01/30/2024
• Device Catalogue Number: 448606
• Device Lot Number: 3038364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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