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	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd phoenix¿ yeast id wrong ids were obtained when testing a panel.The following information was provided by the initial reporter: a c.Auris strain isolated from a urine was mis-identified as c.Auris/haemulonii.The strain was later sent to lspq for full identification and wgs and was confirmed as c.Auris.Following the discovery of that c.Auris case, a diverse panel of 13 c.Auris isolates (representing the 5 clades) was sent to the hospital to assess id performance.Of the 13 strains tested, 11 returned c.Auris/haemulonii and 2 c.Parapsilosis.The c.Parapsilosis repeated, and yielded same id result.The c.Haemulonii mis-id is not surprising as previously reported, but c.Parapsilosis mis-id not documented in the literature.Both mis-id were obtained with clade ii isolates.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: this complaint is for misidentification of candida auris as candida haemulonii and candida parapsilosis when using phoenix panel yid (448316) batch number 3010476.The customer did not return panels but provided isolates and phoenix generated lab reports for the investigation.The lab reports show an organism identified as candida haemulonii and candida parapsilosis.To investigate, two retention panels from complaint batch 3010476 was tested using customer returned isolate c.Haemulonii/auris (1030-lspq-01314) on a phoenix m50 machine and evaluated for identification results.Next, two retention panels from complaint batch 3010476 was tested using customer returned isolate c.Haemulonii/auris (1030-lspq-01315) on a phoenix m50 machine and evaluated for identification results.All four panels identified as c.Haemulonii/auris, 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 two additional complaints on the complaint batch, one of which is related to this defect but unconfirmed.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.
Event or Problem Description
It was reported that bd phoenix¿ yeast id wrong ids were obtained when testing a panel.The following information was provided by the initial reporter: a c.Auris strain isolated from a urine was mis-identified as c.Auris/haemulonii.The strain was later sent to lspq for full identification and wgs and was confirmed as c.Auris.Following the discovery of that c.Auris case, a diverse panel of 13 c.Auris isolates (representing the 5 clades) was sent to the hospital to assess id performance.Of the 13 strains tested, 11 returned c.Auris/haemulonii and 2 c.Parapsilosis (see attached table).The c.Parapsilosis repeated, and yielded same id result.The c.Haemulonii mis-id is not surprising as previously reported, but c.Parapsilosis mis-id not documented in the literature.Both mis-id were obtained with clade ii isolates.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16942572
• Report Number: 1119779-2023-00564
• Device Sequence Number: 20586185
• Product Code: JXB
• UDI-Device Identifier: 30382904483167
• UDI-Public: 30382904483167
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/01/2023

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 Model Number: 448316
• Device Catalogue Number: 448316
• Device Lot Number: UNKNOWN
• 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: 05/01/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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