MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VIPER¿ LT SYSTEM; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS

Catalog Number	442839
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the bd viper¿ lt system, a false positive patient result for hpv genotype 16 was obtained.Physician and patient had doubts about result and a new test was requested.Second sample was collected and retested, and the result was hpv negative.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: this complaint alleges a false positive, a new sample was re-ran by the user and confirmed to be negative, even though the same qc lots were used.Bd field service obtained result reports and log files, but the user reported a negative qc failure.Bd service reached out to the customer and confirmed during a follow up that, the issue was resolved after switching to a new qc lot and performing standard preventative maintenance.This complaint is unconfirmed, however, due to no returned parts the root cause beyond qc lot is unknown.Physical samples were not available to quality for investigation.Dhr review was not required as this did not allege a failure at install or an early life failure.Service history review did not reveal previous complaints for this issue.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.Review of risk management files confirms there are no new or modified risks associated with this failure mode.
Event or Problem Description
It was reported that during use of the bd viper¿ lt system, a false positive patient result for hpv genotype 16 was obtained.Physician and patient had doubts about result and a new test was requested.Second sample was collected and retested, and the result was hpv negative.There was no report of patient impact.

• Brand Name: BD VIPER¿ LT SYSTEM
• Common Device Name: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
• 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: 22287638
• Report Number: 1119779-2025-00604
• Device Sequence Number: 18373252
• Product Code: OOI
• UDI-Device Identifier: 00382904428396
• UDI-Public: (01)00382904428396(11)210608
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K140447
• 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): 11/07/2025

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 Catalogue Number: 442839
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2021
• 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