MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VIPER¿ SYSTEM; DNA REAGENTS, NEISSERIA

Model Number	441091
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(4).Initial reporter facility name: (b)(6) medical center.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 while using the bd viper¿ system that there was a fasle positive.The following information was provided by the initial reporter: customer reports contamination that cause false positive results for ct/gc assay.
Additional Manufacturer Narrative
Investigation summary: "the complaint alleges the instrument viper sp (catalog number 441091 and serial number (b)(6)) had a "false positive".Customer reported contamination that caused false positive results.Instructed customer to decontaminate the instrument and perform em which resolved the issue.This is an unconfirmed failure of the bd product and root cause was unknown.".
Event or Problem Description
It was reported that while using the bd viper¿ system that there was a false positive.The following information was provided by the initial reporter: customer reports contamination that cause false positive results for ct/gc assay.

• Brand Name: BD VIPER¿ SYSTEM
• Common Device Name: DNA REAGENTS, NEISSERIA
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16251366
• Report Number: 1119779-2023-00074
• Device Sequence Number: 5272903
• Product Code: LSL
• UDI-Device Identifier: 00382904410919
• UDI-Public: 00382904410919
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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 Model Number: 441091
• Device Catalogue Number: 441091
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• 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