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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that while using bd affirm¿ vpiii microbial identification test, there was one false positive of a patient result.No patient impact reported.The following information was provided by the initial reporter: "customer reports one patient positive for all targets while using cat 446252 lot 3102251.".
Event or Problem Description
It was reported that while using bd affirm¿ vpiii microbial identification test, there was one false positive of a patient result.No patient impact reported.The following information was provided by the initial reporter: "customer reports one patient positive for all targets while using cat 446252 lot 3102251.".
Additional Manufacturer Narrative
H.6.Investigation summary: this complaint was not confirmed.Quality initiated an investigation on customer claim of one patient positive for all targets on affirm test.Based on a review of the device history record for incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.  functional testing was performed on retention samples with satisfactory results.Photo provided by the customer shows blue color on gardnerella bead.No returned good sample was available.This complaint has not been confirmed for the indicated failure mode of affirm false positive.Complaints received for this device and reported condition will continue to be tracked and trended.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17547455
• Report Number: 2647876-2023-00097
• Device Sequence Number: 12440936
• Product Code: MLA
• UDI-Device Identifier: 00382904462529
• UDI-Public: 00382904462529
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 10/27/2023

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: 02/20/2024
• Device Catalogue Number: 446252
• Device Lot Number: 3102251
• 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: 08/07/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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