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	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during use of the bd viper¿ lt system, about 30 false positive patient results were obtained on the ct/gc/tv assay.Tests were repeated on viper lt and were negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary- the customer reported receiving 30 false positive results over 3-4 runs.The customer performed environmental monitoring, which failed initially, but passed on a second try.The customer reported no further issues after the field service engineer visit.There was a logged escalation and applications was reached out to for further assistance.The customer was told to run negative controls as patient samples to establish a baseline.An fse was dispatched again and replaced (443197 - pipette channel a assy ham vprlt spare) on channel 1 and (443196 - pipette head 1ml ham vprlt spare) on channel 4, performed deck calibration, channel alignments, calibrate lld and z, adjust pip, daily weekly and robot qc and ctgc water run with no errors.The customer was followed up with multiple times, and they confirmed their runs completed with no errors.Instrument is operational.This complaint is unconfirmed, and the root cause is due to contamination.No samples were expected to be received as part of this complaint, and therefore no samples were returned and no returned material investigation could occur.Dhr review is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.Service history for (b)(6) was reviewed and revealed no previous complaints regarding results within the past 24 months.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, about 30 false positive patient results were obtained on the ct/gc/tv assay.Tests were repeated on viper lt and were 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: 21937898
• Report Number: 1119779-2025-00325
• Device Sequence Number: 20131791
• Product Code: OOI
• UDI-Device Identifier: 00382904428396
• UDI-Public: (01)00382904428396(11)150505
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/27/2025

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: 04/01/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2015
• 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