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

Catalog Number	444075
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of bd onclarity¿ hpv assay reagent pack for bd cor, a discrepant patient result was obtained.On 2 different cor runs, the first test was hpv positive, and the second test was hpv negative.Sample was tested the third time using viper lt and gave a negative result.There was no report of patient impact.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: bd initiated an investigation regarding customer concern about a discrepant result for a patient sample, which required review of the customer complaint history, review of the bhr records, review of the customer provided run files, and retain testing of the available hpv reagents.Review of the bhr records did not indicate any discrepancies or issues.The retain testing of the available hpv reagents did not demonstrate any abnormalities; the reagents passes acceptance criteria for release.Review of the customer provided information and materials demonstrated that the patient sample in question was negative in the first run, as well as the negative control sample.Bd observed that in the second run the sample in question was positive for hpv 45.According to the customer, the sample was processed on the viper to resolve the discrepant result.In the first run, in which the negative control failed and produced invalid results for all samples involved, the system employed several automated quality control checks, determining that the signals did not adequately meet the criteria of an amplified reaction to result in a positive call.The purpose of this quality check in the algorithm is to prevent false positive results from being reported to the clinician and patients.In the second run, in which the patient result was valid since both quality controls passed, the patient sample in question was positive for hpv 45, and per bd labeling guidelines, additional testing for the patient sample is not recommended.Lastly, the bd hpv assay according to the ifu is not 100% sensitive or specific since detection is dependent on the number of copies present in the sample, stage of infection, presence of interfering substances, etc.In conclusion, while the bd hpv onclarity¿ assay automated algorithms have high accuracy, bd acknowledges that discrepancies may occur and are expected when repeating samples.Bd understands that the customer values quality and accuracy and will continue to monitor and investigate issues raised by the customer.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.
Event or Problem Description
It was reported that during use of bd onclarity¿ hpv assay reagent pack for bd cor, a discrepant patient result was obtained.On 2 different cor runs, the first test was hpv positive, and the second test was hpv negative.Sample was tested the third time using viper lt and gave a negative result.There was no report of patient impact.

• Brand Name: BD ONCLARITY¿ HPV ASSAY REAGENT PACK FOR BD COR
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22162306
• Report Number: 1119779-2025-00540
• Device Sequence Number: 15622907
• Product Code: MAQ
• UDI-Device Identifier: 00382904440756
• UDI-Public: (01)00382904440756(11)250409(17)260411(10)5099266
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 09/16/2025

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: 04/11/2026
• Device Catalogue Number: 444075
• Device Lot Number: 5099266
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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