MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD VIPER¿ LT SYSTEM; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS

Model Number	442839
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: a failure of discrepant results was reported on a viper lt instrument (p/n 442839, s/n (b)(6) ).The customer reported that there was a discrepancy in the patient results between their viper lt and a separate platform.Bd field service recommended the customer perform environmental sampling to determine if there was a contamination issue.The testing showed no contamination, and the customer was unable to replicate the discrepant results.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 positive failures.The root cause is unknown, since the reported issue could not be replicated by the user or bd field service.
Event or Problem Description
It was reported that while using bd viper¿ lt system there was a false positive of one patient sample.There was no patient impact reported.The following information was provided by the initial reporter: "there have been several instances of discrepant positive results on the viper lt.The result was positive for ct on the viper lt but negative on the cepheid geneexpert.".

• Brand Name: BD VIPER¿ LT SYSTEM
• Common Device Name: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
• 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: 17317056
• Report Number: 1119779-2023-00772
• Device Sequence Number: 19848079
• Product Code: OOI
• UDI-Device Identifier: 00382904428396
• UDI-Public: 00382904428396
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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: 442839
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2020
• 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