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	03/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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¿ yeast id, a patient isolate was misidentified as cryptococcus neoformans.The bacterial culture and gram stain did not match the morphology for the results given.The result was verified using the maldi, giving the result candida pseudohaemulonii.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary this complaint is for misidentification of candida pseudohaemulonii as cryptococcus neoformans when using phoenix panel yeast id (catalog number 448316) batch number 3241307.The customer did not provide isolate returns or panel returns but provided phoenix generated lab reports and photos for the investigation.The photos show the panel carton with batch number present and growth on an agar plate.The lab reports show identifications of c.Neoformans when using the complaint batch.It is to be noted that bd phoenix does not have identification claims for c.Pseudohaemulonii.This complaint is not confirmed.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.
Event or Problem Description
It was reported while using the bd phoenix¿ yeast id, a patient isolate was misidentified as cryptococcus neoformans.The bacterial culture and gram stain did not match the morphology for the results given.The result was verified using the maldi, giving the result candida pseudohaemulonii.No health impact or consequence reported.

• 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: 19197123
• Report Number: 1119779-2024-00317
• Device Sequence Number: 18222988
• Product Code: JXB
• UDI-Device Identifier: 30382904483167
• UDI-Public: (01)30382904483167
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: 08/21/2024
• Device Catalogue Number: 448316
• Device Lot Number: 3241307
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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