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

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	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd onclarity hpv assay 5 specimens were run and tested positive for all genotypes.They were repeated and tested negative on the cor.No injuries were reported.The following information was provided by the initial reporter: they had a full hpv run and 5 patient samples were affected and samples were positive for all genotypes.Customer re-aliquot the specimen and repeated using their cor.The specimen repeated negative for all genotypes and the pap test was also negative.
Additional Manufacturer Narrative
The following fields were corrected.B5.Describe event or problem: it was reported that bd onclarity hpv assay 1 specimen was run and tested positive for all genotypes.They were repeated and tested negative on the cor.No injuries were reported.The following information was provided by the initial reporter: they had a full hpv run and 1 patient sample was affected and samples were positive for all genotypes.Customer re-aliquot the specimen and repeated using their cor.The specimen repeated negative for all genotypes and the pap test was also negative.
Event or Problem Description
It was reported that bd onclarity hpv assay 1 specimen was run and tested positive for all genotypes.They were repeated and tested negative on the cor.No injuries were reported.The following information was provided by the initial reporter: they had a full hpv run and 1 patient sample was affected and samples were positive for all genotypes.Customer re-aliquot the specimen and repeated using their cor.The specimen repeated negative for all genotypes and the pap test was also negative.
Additional Manufacturer Narrative
H.6 investigation summary: bd investigation required review of the batch history records from the customers reported reagent batch and complaint trending review.The batch history records were reviewed and no discrepancies were noted.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 specimen was initially positive on the viper lt and subsequently negative on bd cor.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.There was no corrective action taken at this time.
Event or Problem Description
It was reported that bd onclarity hpv assay 1 specimen was run and tested positive for all genotypes.They were repeated and tested negative on the cor.No injuries were reported.The following information was provided by the initial reporter: they had a full hpv run and 1 patient sample was affected and samples were positive for all genotypes.Customer re-aliquot the specimen and repeated using their cor.The specimen repeated negative for all genotypes and the pap test was also negative.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16153188
• Report Number: 1119779-2023-00025
• Device Sequence Number: 7051618
• Product Code: MAQ
• UDI-Device Identifier: 00382904419905
• UDI-Public: 00382904419905
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 01/30/2023

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: 01/06/2023
• Supplement Date Received by Manufacturer: 01/13/2023; 01/30/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 01/19/2023; 02/02/2023
• 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