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	02/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phoenix¿ yeast id misidentified the organism as candida tropicalis instead of candida auris.This occurred 25 separate times during use.Confirmatory testing was done on another instrument, which identified the correct organism.There was no indication that results were reported to clinicians, and there was no report of patient impact.The following information was provided by the initial reporter: "yid panels are given wrong identification like candida tropicalis instead of candida auris but on different instrument it has identified correct organsim.".
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 the bd phoenix¿ yeast id misidentified the organism as candida tropicalis instead of candida auris.This occurred 25 separate times during use.Confirmatory testing was done on another instrument, which identified the correct organism.There was no indication that results were reported to clinicians, and there was no report of patient impact.The following information was provided by the initial reporter: "yid panels are given wrong identification like candida tropicalis instead of candida auris but on different instrument it has identified correct organsim.".
Additional Manufacturer Narrative
H.6# this complaint is not confirmed.This complaint is for misidentification of candida auris as candida tropicalis when using phoenix panel yid ((b)(4)) batch number 1201556.The customer did not return lab reports, panels, or isolates for investigation.Candida auris is not listed on either taxa list for the phoenix 100 or phoenix m50 instrument.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.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.Per baltrmphxidastaph rev 10 version h, id 6.0-6.11, indicates the potential risk of a mis-identification was assessed as s4.

• 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: 13699122
• Report Number: 1119779-2022-00391
• Device Sequence Number: 19911986
• Product Code: JXB
• UDI-Device Identifier: 30382904483167
• UDI-Public: 30382904483167
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 06/26/2022

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: 02/11/2022
• Supplement Date Received by Manufacturer: 06/26/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 07/21/2022
• 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