MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES BD FACSLYRIC¿ 3L10C INSTRUMENT; FLOW CYTOMETRIC REAGENTS AND ACCESS

Catalog Number	662878
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with bd facslyric¿ 3l10c instrument an "arm board" error was bypassed while running patient samples.Patient impact was not reported.The following information was provided by the initial reporter: cx says they are having a persistent ""arm board"" error where it is preventing running of their clinical samples.1.Are you running patient samples for diagnostic test?(if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there an error message? (if yes, go to question #3.If no, no further questions required.): yes.3.Did the customer bypass the error message? ((if yes, go to question #4.If no, no further questions required.): yes.
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.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
The following fields have been updated with corrected and/or additional information: reporting office: becton dickinson and company bd biosciences.Reporting office contact: fahmy razak - mdr.Manufacturing site contact: fahmy razak - mdr.H.6: based on the investigation results, the reported issue of ¿arm board¿ error messaged showing up during sample runs was confirmed.The potential cause of the issue was determined to be a defective loader/ual.After the fse replaced and calibrated the ual, reinstalled the firmware, and ran tests, the instrument was found to be working as expected.The issue was with the ual and not the lyric itself, and this issue did not impact patient diagnosis or treatment.Review of the dhr confirmed that the instrument met all the manufacturing specifications prior to release.A return sample was not requested for evaluation as the complaint was confirmed through other elements of the investigation.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that during use with bd facslyric¿ 3l10c instrument an "arm board" error was bypassed while running patient samples.Patient impact was not reported.The following information was provided by the initial reporter: cx says they are having a persistent ""arm board"" error where it is preventing running of their clinical samples.1.Are you running patient samples for diagnostic test?(if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there an error message? (if yes, go to question #3.If no, no further questions required.): yes.3.Did the customer bypass the error message? ((if yes, go to question #4.If no, no further questions required.): yes.

• Brand Name: BD FACSLYRIC¿ 3L10C INSTRUMENT
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESS
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 17960840
• Report Number: 2916837-2023-00200
• Device Sequence Number: 17901300
• Product Code: OYE
• UDI-Device Identifier: 00382906628787
• UDI-Public: (01)00382906628787
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201814
• 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): 04/05/2024

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 Catalogue Number: 662878
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• 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