MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD ONCLARITY HPV ASSAY; HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD

Catalog Number	441990
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Report 1 of 3.It was reported that bd onclarity hpv assay 3 specimens were run and came out positive.After recollection the specimens came back negative.The following information was provided by the initial reporter: per customer, 3 specimens were run for bd onclarity hpv assay and came out pos.After recollection a couple of months apart all specimens were negative.Customer sent all 6 specimens (3 patients) for confirmation, and all specimens were negative except 2 were inconclusive.
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.H.4.Device manufacture date: unknown.D4.Lot- unknown.D.4.Medical device expiration date: unknown.
Additional Manufacturer Narrative
H.6.Investigation summary: bd integrated diagnostic systems initiated an investigation into discrepant results on the bd viper lt system (catalog # 441990, batch # 2297345).Bd investigation required review of the batch history records, functional analysis of customers reported reagent batch and complaint history review.The batch history records were reviewed, and no discrepancies were noted.Functional analysis of the customers reported reagent batch was performed and met acceptance criteria.Bd was unable to confirm the customers reported complaint.There are no current trends associated with discrepant results on the bd viper lt system.The following fields have been updated with corrected and/or additional information: d4.Medical device lot#: 2297345.D4.Medical device expiration date: 06-oct-2023.H4.Device manufacture date: 24-oct-2023 h3 other text : see h.10.
Event or Problem Description
Report 1 of 3.It was reported that bd on clarity hpv assay 3 specimens were run and came out positive.After recollection the specimens came back negative.The following information was provided by the initial reporter: per customer, 3 specimens were run for bd on clarity hpv assay and came out pos.After recollection a couple of months apart all specimens were negative.Customer sent all 6 specimens (3 patients) for confirmation, and all specimens were negative except 2 were inconclusive.

• Brand Name: BD ONCLARITY HPV ASSAY
• Common Device Name: HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17474482
• Report Number: 1119779-2023-00844
• Device Sequence Number: 12635346
• Product Code: MAQ
• UDI-Device Identifier: 00382904419905
• UDI-Public: 00382904419905
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P160037
• 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): 12/15/2023

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: 10/06/2023
• Device Catalogue Number: 441990
• Device Lot Number: 2297345
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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