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

Model 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	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd phoenix¿ yeast id mis identification occurred.The following information was provided by the initial reporter: the colony properties of the medium and the judgment result of the panel are not accompanied.White colonies on candida medium (nissui).When purely isolated in ketsukan (nisui) and measured with the m50yeast panel, it was identified as c.Albicans.The first was unidentifiable and the second was c.Albicans.From the colony characteristics, c.Albicans is unlikely.
Event or Problem Description
It was reported that bd phoenix¿ yeast id mis identification occurred.The following information was provided by the initial reporter: the colony properties of the medium and the judgment result of the panel are not accompanied.White colonies on candida medium (nissui).When purely isolated in ketsukan (nisui) and measured with the m50yeast panel, it was identified as c.Albicans.The first was unidentifiable and the second was c.Albicans.From the colony characteristics, c.Albicans is unlikely.
Additional Manufacturer Narrative
H.6 investigation summary: this complaint is not confirmed.This complaint is for misidentification when using phoenix panel yid (448316) batch number 2019560.The customer did not return panels, lab reports or isolates for the investigation.To investigate, three (3) retention panels from the complaint batch 2019560 were tested using qc isolate c.Papapsilosis (20019) and evaluated for identification results.In addition, three (3) retention panels from the complaint batch 2019560 were tested using qc isolate c.Albicans (24433) and evaluated for identification results.During investigation, all six(6) panels identified correctly.Therefore, this complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed no additional complaints on the complaint batch.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16251365
• Report Number: 1119779-2023-00073
• Device Sequence Number: 5272902
• Product Code: JXB
• UDI-Device Identifier: 30382904483167
• UDI-Public: 30382904483167
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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: 02/28/2023
• Device Model Number: 448316
• Device Catalogue Number: 448316
• Device Lot Number: 2019560
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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