MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST; DNA PROBE, YEAST

Catalog Number	446252
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the bd affirm¿ vpiii microbial identification test, an unspecified number of patient samples were either candida sp.Or gardnerella false positive.Customer may perform a wet prep to confirm presence of yeast, and may send specimens for pap smears or "next gen" testing.Customer did not know if confirmatory testing was done for all questionable results.No patient impact was reported.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: b5: describe event: "false positive" corrected to "false negative".Investigation summary: bd quality initiated an investigation on customer claim of false negative results on affirm catalog # 446252, batch # 3346388.Batch history review was performed on the finished product and its components with satisfactory results.In process and qc testing were within specifications.Visual inspection was performed on retention samples with satisfactory results.Functional and specificity testing was also performed on retention samples with satisfactory results.This complaint was unable to be confirmed for affirm false negative results.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.
Event or Problem Description
It was reported that during use of the bd affirm¿ vpiii microbial identification test, an unspecified number of patient samples were either candida sp.Or gardnerella false negative.Customer may perform a wet prep to confirm presence of yeast, and may send specimens for pap smears or "next gen" testing.Customer did not know if confirmatory testing was done for all questionable results.No patient impact was reported.

• Brand Name: BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST
• Common Device Name: DNA PROBE, YEAST
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19269135
• Report Number: 2647876-2024-00069
• Device Sequence Number: 15292509
• Product Code: MLA
• UDI-Device Identifier: 00382904462529
• UDI-Public: (01)00382904462529
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 07/03/2024

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: 10/15/2024
• Device Catalogue Number: 446252
• Device Lot Number: 3346388
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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