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

Model Number	441091
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd viper¿ system has had an increase of sale negative samples.The following information was provided by the initial reporter: the customer informed that has notice an increase of false negatives samples.The internal controls pass but repeating a dummy run with already known positive samples, one became negative and one positive with a low value.
Event or Problem Description
It was reported that while using bd viper¿ system has had an increase of sale negative samples.The following information was provided by the initial reporter: the customer informed that has notice an increase of false negatives samples.The internal controls pass but repeating a dummy run with already known positive samples, one became negative and one positive with a low value.
Additional Manufacturer Narrative
H.6.Investigation summary: the complaint alleges the bd viper xtr instrument (catalog number 441091 and serial number (b)(6)) had "false negatives".Customer reported that they have noticed an increase in suspected false negative results and that internal controls pass but repeat testing of known positive samples sometimes gives a negative result.Remote assistance was provided to the customer to help investigate the issue.No instrument issues were identified by service, and it was determined that the issue it likely caused by a build-up of bleach reside on the instrument which can cause low level assay inhibition.This complaint is unconfirmed as it alludes to a cleaning workflow issue.The root cause was determined to be assay target inhibition.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.Review of device history record for instrument (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and the complaint is unconfirmed, thus a dhr review would yield no useful information.Service history review was performed for the instrument (b)(6), and no additional work orders were observed for the complaint failure mode reported.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16969910
• Report Number: 1119779-2023-00578
• Device Sequence Number: 14815817
• Product Code: LSL
• UDI-Device Identifier: 00382904410919
• UDI-Public: 00382904410919
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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: 04/24/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 08/17/2023
• 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