MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VIPER¿ LT SYSTEM; THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY

Catalog Number	442839
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
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 bd viper¿ lt system, a chlamydia trachomatis and neisseria gonorrhoea contamination occurred, which gave an unspecified number of false positive results.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the customer reported suspected ct/gc contamination on vlt1010 after observing an unusually high positivity rate during a ctgc run on despite the fact that qc passed.The issue followed an aborted run caused by improper film placement that prevented the reader from scanning the plate.The customer cleaned the instrument and subsequent runs initially worked normally.Support recommended performing an extended environmental monitoring (em) run, cleaning the instrument and workspace, and completing a second em run before resuming patient testing.However, the customer later confirmed they had discontinued ctgc testing due to the assay¿s end of life and were transitioning to ctgctv2 on bd max, and they did not have reagents available to continue troubleshooting.The customer agreed to close all open ctgc related cases for instrument vlt1010.This complaint is unconfirmed, and the root cause appears to be due to contamination.No parts were replaced as part of this complaint; therefore, no samples were returned.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 review for vlt1010 has not revealed any previous cases regarding results issues within the past 12 months.
Event or Problem Description
It was reported that during use of bd viper¿ lt system, a chlamydia trachomatis and neisseria gonorrhoea contamination occurred, which gave an unspecified number of false positive results.There was no report of patient impact.

• Brand Name: BD VIPER¿ LT SYSTEM
• Common Device Name: THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY
• 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: 23280980
• Report Number: 1119779-2025-05107
• Device Sequence Number: 12963973
• Product Code: OOI
• UDI-Device Identifier: 00382904428396
• UDI-Public: (01)00382904428396
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 02/02/2026

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: 09/18/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2022
• 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