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

Model Number	442843
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
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 bd viper¿ system, remanufactured has been giving increased amount of positive results after a spill occurred where wells are placed for controls and patients but can not be reproduced on second testing platform.The following information was provided by the initial reporter: when removing tray from instrument, tray with sticky covered was dropped upside down onto 4 stations on right side where wells are placed and spilled liquid here.Since then, the customer has been getting increased positive results for controls and patient samples which cannot be reproduced with another platform.
Additional Manufacturer Narrative
H.6 investigation summary the complaint of "ct and hpv contamination after spill" was received against instrument bd viper remanufactured material number: 442843, serial number: (b)(6).A bd field service engineer (fse) was dispatched.The fse was replaced both tip exchanges, removed both readers and cleaned all components, thus the issue was resolved.Instrument was found to be operational and released to the customer for regular use.This is an unconfirmed complaint, and the root cause was unable to be determined.Device history record review for the instrument (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 review revealed no previous complaints for this issue.No parts were replaced as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this complaint.
Event or Problem Description
It was reported that bd viper¿ system, remanufactured has been giving increased amount of positive results after a spill occurred where wells are placed for controls and patients but can not be reproduced on second testing platform.The following information was provided by the initial reporter: when removing tray from instrument, tray with sticky covered was dropped upside down onto 4 stations on right side where wells are placed and spilled liquid here.Since then, the customer has been getting increased positive results for controls and patient samples which cannot be reproduced with another platform.

• Brand Name: BD VIPER¿ SYSTEM, REMANUFACTURED
• 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: 16200660
• Report Number: 1119779-2023-00036
• Device Sequence Number: 5382391
• Product Code: LSL
• UDI-Device Identifier: 00382904428433
• UDI-Public: 00382904428433
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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: 442843
• Device Catalogue Number: 442843
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2016
• 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