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	07/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that while using bd phoenix¿ yeast id the customer received discrepant results between two instruments.Confirmatory tests determined that misidentification had occurred.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "the customer use yeast id panel for yeast identification.The panel result from phoenix 100 is c.Krusei, and the result from phoenix m50 is p.Wickerhamii.The customer rechecked the result with maldi-tof, the final id is c.Krusei.".
Event or Problem Description
It was reported that while using bd phoenix¿ yeast id the customer received discrepant results between two instruments.Confirmatory tests determined that misidentification had occurred.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "the customer use yeast id panel for yeast identification.The panel result from phoenix 100 is c.Krusei, and the result from phoenix m50 is p.Wickerhamii.The customer rechecked the result with maldi-tof, the final id is c.Krusei.".
Additional Manufacturer Narrative
H.6 investigation summary: this complaint is not confirmed.This complaint is for misidentification of c.Krusei as p.Wickerhamii when using phoenix panel yid (448316) batch number 1201556.The complaint batch was not available for investigation due to the batch being expired at the time of the investigation and is beyond our stability timeframe.As a result, this complaint is not confirmed for performance.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed one additional complaint on the complaint batch.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.Please continue to communicate any additional concerns.H3 other text : see h.10.

• 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: 15229489
• Report Number: 1119779-2022-01110
• Device Sequence Number: 11289983
• Product Code: JXB
• UDI-Device Identifier: 30382904483167
• UDI-Public: 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,Followup
• Report Date (Section B): 01/09/2023

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: 08/31/2022
• Device Model Number: 448316
• Device Catalogue Number: 448316
• Device Lot Number: 1201556
• 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: 08/11/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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