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

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	03/13/2026
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 false positive hpv patient result with an unusual pcr curve was obtained.There was no report of patient impact.This is report 2 of 12.

• Brand Name: VIPER
• 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: 24844070
• Report Number: 1119779-2026-00652
• Device Sequence Number: 21064540
• Product Code: OOI
• UDI-Device Identifier: 00382904428396
• UDI-Public: (01)00382904428396
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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: 03/13/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• 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