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	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.E1: initial reporter addr 1: (b)(6).
Event or Problem Description
It was reported that bd on clarity hpv assay gave a positive result on one patient sample, showing two dashes instead of an acceptable result symbol.Customer repeated and results were negative for both original sample and a new aliquot from surepath vial.
Event or Problem Description
It was reported that bd onclarity hpv assay gave a positive result on one patient sample, showing two dashes instead of an acceptable result symbol.Customer repeated and results were negative for both original sample and a new aliquot from surepath vial.
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 # unknown).Bd investigation required complaint trending review.There are no current trends associated with discrepant results on the bd viper lt system.Bd was unable to confirm the customers report.Bd was unable to perform functional analysis and batch history record review due to the lack of batch information provided in the customer report.No corrective actions were taken at this time.H3 other text : see h.10.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18096949
• Report Number: 1119779-2023-01209
• Device Sequence Number: 5697330
• Product Code: MAQ
• UDI-Device Identifier: 00382904419905
• UDI-Public: (01)00382904419905
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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 Catalogue Number: 441990
• Device Lot Number: SEE H.10
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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