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

Model Number	446252
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter addr 1: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device lot #:2077353, medical device expiration date: 2022-12-14, and device manufacture date: 2022-03-18.Medical device lot #:2090679, medical device expiration date: 2023-01-24, and device manufacture date: 2022-03-31.Medical device lot #:2129244, medical device expiration date: 2023-03-21, and device manufacture date: 2022-05-09.Medical device lot #:2108240, medical device expiration date: 2023-03-14, and device manufacture date: 2022-04-18.Medical device lot #:2151435, medical device expiration date: 2023-04-11, and device manufacture date: 2022-05-31.Medical device lot #:2175675, medical device expiration date: 2023-05-17, and device manufacture date: 2022-06-10.Medical device lot #:2161623, medical device expiration date: 2023-05-10, and device manufacture date: 2022-06-10.
Event or Problem Description
It was reported that while using bd affirm¿ vpiii microbial identification test that there was fasle positives.It was reported that 7 lots were involved.The following information was provided by the initial reporter: affirm 446252 - kit affirm vpiii clinical positive rate increase for trichomonas assay.
Event or Problem Description
It was reported that while using bd affirm¿ vpiii microbial identification test that there was fasle positives.It was reported that 7 lots were involved.See h.10.The following information was provided by the initial reporter: affirm 446252 - kit affirm vpiii clinical positive rate increase for trichomonas assay.
Additional Manufacturer Narrative
Quality initiated an investigation on trichomonas positive increase customer claim on material 446252, batches 2151435, 2175675, 2108240, 2129244, 2161623.Functional test showed satisfactory results when retention samples were tested.Visual inspection was performed to the retention with satisfactory results.No returned goods sample was available.Batch history record review was performed to the finished product with satisfactory results.In process and qc testing were within specifications.Complaint unconfirmed.H3 other text : see h.10.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16073602
• Report Number: 1119779-2022-01556
• Device Sequence Number: 20391947
• Product Code: MLA
• UDI-Device Identifier: 00382904462529
• UDI-Public: 00382904462529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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: 05/10/2023
• Device Model Number: 446252
• Device Catalogue Number: 446252
• Device Lot Number: 2161623
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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