MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ YEAST ID; KIT, IDENTIFICATION, YEAST

Catalog Number	448316
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	11/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6.Investigation summary: this complaint is for misidentification with lodderomyces elongisporus as cryptococcus luteolus when using phoenix panel yeast id (catalog number 448316) batch number 3045467.The customer did not provide isolate returns or panel returns but provided phoenix generated lab reports for the investigation.The lab reports show phoenix results for cryptococcus luteolus and maldi results for lodderomyces elongisporus.Investigation of the panel inserts show no claims for lodderomyces elongisporus with yeast panels.This complaint is not confirmed.A review of quality notifications revealed no quality notifications for the complaint batch.A review of complaints revealed one additional complaint 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.
Event or Problem Description
It was reported that during use with the bd phoenix¿ yeast id, a sample of lodderomyces elongisporus was misidentified as cryptococcus luteolus.Confirmatory testing was done on maldi.There was no report of patient impact.

• Brand Name: BD PHOENIX¿ YEAST ID
• Common Device Name: KIT, IDENTIFICATION, YEAST
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18552435
• Report Number: 1119779-2024-00036
• Device Sequence Number: 6402337
• Product Code: JXB
• UDI-Device Identifier: 30382904483167
• UDI-Public: (01)30382904483167
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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: 02/10/2024
• Device Catalogue Number: 448316
• Device Lot Number: 3045467
• 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: 12/27/2023
• Initial Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• 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