MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD ONCLARITY HPV ASSAY; SEE H.10

Model Number	441990
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: human papillomavirus high-risk strain nucleic acid ivd.Initial reporter address 1: (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd onclarity hpv assay that there was a false positive.The following information was provided by the initial reporter: customer reports that 2 pos patient results for hpv test were questioned by a physician, and the repeats were neg for both samples; first sample was initially ran on (b)(6)2022 and was pos for genotype 16; hen it was repeated on (b)(6)2023 on the same vlt0257, and the result was neg; sample was stored at rt in thinprep vial; second sample was initially tested on vlt0257 on (b)(6)2022, and was pos for genotype 31; it was repeated "in two weeks" on non-bd instrument, and was neg.
Additional Manufacturer Narrative
H6.Investigation summary: bd integrated diagnostic solutions initiated investigation on the customer report regarding two (2) hpv specimen obtained discordant results on the bd viper lt system.Bd investigation required review of the batch history records, functional analysis from the customers reported reagent batch (catalog # 441990, batch # 2227879) and complaint trending review.The batch history records were reviewed and no discrepancies were noted.Functional analysis of the retention material resulted in 100% hpv positivity for positive controls and 100% hpv and hbb negativity for negative controls.Bd was unable to duplicate the customer complaint.Review of the past year of complaints reveals there are no complaint trends related to hpv discordant results on the bd viper lt system.It is unknown why the given specimens were initially positive on the viper lt and subsequently negative after repeated.If further discordants are encountered, please submit an instrument complaint against the bd viper lt system and submit log files for analysis.Bd will continue to closely monitor for trends associated with hpv discordant results.
Event or Problem Description
It was reported that while using the bd onclarity hpv assay that there was a false positive.The following information was provided by the initial reporter: - customer reports that 2 pos patient results for hpv test were questioned by a physician, and the repeats were neg for both samples; - first sample was initially ran on (b)(6) 2022 and was pos for genotype 16; then it was repeated on (b)(6) 2023 on the same vlt0257, and the result was neg; sample was stored at rt in thinprep vial; - second sample was initially tested on vlt0257 on (b)(6) 2022, and was pos for genotype 31; it was repeated "in two weeks" on non-bd instrument, and was neg.

• Brand Name: BD ONCLARITY HPV ASSAY
• Common Device Name: SEE H.10
• 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: 16318461
• Report Number: 1119779-2023-00110
• Device Sequence Number: 7993295
• Product Code: MAQ
• UDI-Device Identifier: 00382904419905
• UDI-Public: 00382904419905
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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: 08/03/2023
• Device Model Number: 441990
• Device Catalogue Number: 441990
• Device Lot Number: 2227879
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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