MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VIPER¿ LT SYSTEM; SEE H.10

Model Number 442839

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd viper¿ lt system that there was a false negative.The following information was provided by the initial reporter: we checked with the responsible engineer, and the correct description of the event is "false negative".

Manufacturer Narrative

D.3 common device name: instrumentation for clinical multiplex test systems.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd viper¿ lt system that there was a false negative.The following information was provided by the initial reporter: we checked with the responsible engineer, and the correct description of the event is "false negative.".

Manufacturer Narrative

H.6.Investigation summary: a failure of false results was reported on a viper lt instrument (p/n 442839, s/n (b)(6)).The customer reported false negative results.A bd field service engineer was dispatched and extracted log files.However, there was not enough information provided to confirm the complaint.This is an unconfirmed failure of a bd product.Bd quality did not receive any returned materials for review.Review of device history record for (b)(6) 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 related to false negative results.The root cause is unknown, as there was no follow up on the extracted log file analysis.

• Brand Name: BD VIPER¿ LT SYSTEM
• Type of Device: SEE H.10
• 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: 17100727
• MDR Text Key: 316969901
• Report Number: 1119779-2023-00635
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904428396
• UDI-Public: 00382904428396
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K140447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

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
• Device Operator: Other
• Device Model Number: 442839
• Device Catalogue Number: 442839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1