MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES BD FACSCANTO¿ II; COUNTER, DIFFERENTIAL CELL

Catalog Number	338962
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	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd facscanto¿ ii they saw error messages they were able to bypass.The following information was provided by the initial reporter: mdr safety checklist - error messages.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.4.Is this presto? (either yes or no, no further questions required): no.Error e089.They have fluidics board requested shutdown messages.
Additional Manufacturer Narrative
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: g.1.Reporting office: (b)(6) g.2.Reporting office contact: (b)(6) g.4.Manufacturing site contact: (b)(6) h.6.Imdrf annex f grid: f26 h.6.Investigation summary: based on the investigation results, the reported issue with the carousel door error eo89 was confirmed.Investigation results that were performed on the indicated failure mode were the following: based on the complaint trend, defect trend, dhr, risk analysis and service activity review, the complaint was confirmed, and the potential cause of the carousel door error was determined to be the lowering and lifting of tube timing and the cable between the cytometer and the carousel was not properly seated.The fse adjusted the lifting and lowering and reseated the cable.The instrument was functioning as expected.No one was harmed or injured, and no patients were diagnosed or treated based on any erroneous results.The safety risk of this hazard has been identified to be within the acceptable level.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.H3 other text : see h.10.
Event or Problem Description
It was reported that while using bd facscanto¿ ii they saw error messages they were able to bypass.The following information was provided by the initial reporter: mdr safety checklist - error messages 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 4.Is this presto? (either yes or no, no further questions required): no ) error e089.They have fluidics board requested shutdown messages.

• Brand Name: BD FACSCANTO¿ II
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• 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: 18050588
• Report Number: 2916837-2023-00211
• Device Sequence Number: 8026368
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: (01)00382903389629
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K141468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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: 338962
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2016
• 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