MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST; DNA PROBE, YEAST

Catalog Number	446252
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use with the bd affirm¿ vpiii microbial identification test, a patient tested positive for gardnerella vaginalis.The provider prescribed medication and questioned the result after the patient continued to test positive for gardnerella post treatment.Report 1 of 5.
Additional Manufacturer Narrative
D4.Medical device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H4.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use with the bd affirm¿ vpiii microbial identification test, a patient tested positive for gardnerella vaginalis.The provider prescribed medication and questioned the result after the patient continued to test positive for gardnerella post treatment.Report 1 of 5.
Additional Manufacturer Narrative
H.6.Investigation summary: bd did not receive returned samples or photos for investigation into customer claim of affirm gardnerella vaginalis (gv) false positives.Additionally, incident lot # was unable to be determined, so review of device history record and retention testing could not be conducted.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.This complaint was unable to be confirmed for affirm gv false positives.Bd was unable to identify a root cause for indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST
• Common Device Name: DNA PROBE, 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: 19197418
• Report Number: 1119779-2024-00318
• Device Sequence Number: 15543917
• Product Code: MLA
• UDI-Device Identifier: 00382904462529
• UDI-Public: (01)00382904462529
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K931374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 446252
• 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: 03/29/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female