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

Catalog Number	442839
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Additional phone number is listed as follows: (b)(6).H.3.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 onclarity hpv assay, there was contamination of one box of plates.No patient impact reported.The following information was provided by the initial reporter: "customer reports contamination due to instrument issue while using cat 441990 lot 3132981.".
Additional Manufacturer Narrative
The following fields have been corrected: b5 describe event or problem: it was reported that while using bd viper¿ lt system there were false positives reported.No patient impact reported.The following information was provided by the initial reporter: customer reports contamination due to instrument issue while using cat 441990 lot 3132981.Dropped tip that cause contamination as well as run results showing contaminated run.Was this issue involving patient or non-patient samples (qc, validation testing or proficiency samples)? patient.D1: medical device brand name: bd viper¿ lt system.D2a: common device name: instrumentation for clinical multiplex test systems.D2b: medical device type or (procode): ooi.D4.Medical device catalog#: 442839.D4.Serial number: (b)(6).D4.Udi: (b)(4).G5.Pma/510k #: k140447.H6.Investigation summary: complaint reports contamination associated with viper lt (catalog number 442839) serial number (b)(6).Complaint alleges instrument dropped tip causing contamination.Service replaced the reader compliant pad, o-ring and tip on channel two.Service then decontaminated and cleaned instrument.Service performed environmental test, no evidence of environmental contamination.Post intervention the instrument is operating normally.Root cause attributed to a faulty reader channel.This complaint is a confirmed failure of the instrument based on the service investigation.Review of device history record for instrument serial number, (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Device was installed on 07/24/2019.Service history review was performed for the instrument (b)(6), and no additional work orders were observed for the complaint failure mode reported.Review of risk management files confirms there are no new or modified risks associated with this failure mode.There is no corrective and preventative action plan in place.Bd quality will continue to monitor for trends associated with failure of "results.".
Event or Problem Description
It was reported that while using bd viper¿ lt system there were false positives reported.No patient impact reported.The following information was provided by the initial reporter: customer reports contamination due to instrument issue while using cat 441990 lot 3132981.Dropped tip that cause contamination as well as run results showing contaminated run.Was this issue involving patient or non-patient samples (qc, validation testing or proficiency samples)? patient.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17547454
• Report Number: 1119779-2023-00885
• Device Sequence Number: 6714075
• Product Code: OOI
• UDI-Device Identifier: 00382904428396
• UDI-Public: 00382904428396
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/16/2023
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 05/23/2024
• Device Catalogue Number: 442839
• Device Lot Number: 3132981
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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