MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD; COUNTER, DIFFERENTIAL CELL

Catalog Number	338960
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	10/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 bd facscanto ii cytometer 4/2 system ivd sensor error came on while running patient samples.The following information was provided by the initial reporter: waste sensor error 1.Are you running patient samples for diagnostic test? ans.Yes.2.Was there an error message? ans.Yes.3.Did the customer bypass the error message? ans.Yes.4.Is this presto? ans.No.
Event or Problem Description
It was reported that bd facscanto ii cytometer 4/2 system ivd sensor error came on while running patient samples and error was bypassed.The following information was provided by the initial reporter: waste sensor error.1.Are you running patient samples for diagnostic test? ans.Yes.2.Was there an error message?.Ans.Yes.3.Did the customer bypass the error message? ans.Yes.4.Is this presto? ans.No.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: b.5.Describe event or problem: it was reported that bd facscanto ii cytometer 4/2 system ivd sensor error came on while running patient samples and error was bypassed.G.1 - reporting office - (b)(6).H.6 imdrf annex f code: f26.Investigation summary: based on the investigation results, the reported issue of a waste sensor error was confirmed.Investigation results that were performed on the indicated failure mode were the following: the complaint trend and service notes were reviewed.The potential cause for a waste sensor error was due to a worn waste sensor.The issue was resolved after the part was replaced.No further problems were noted and the instrument was confirmed to be functioning as expected.Although the instrument was used for diagnostic testing, the issue was resolved before the patient sample results were used for any diagnosis or treatment.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.

• Brand Name: BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD
• 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: 17991315
• Report Number: 2916837-2023-00204
• Device Sequence Number: 15503646
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 0382903389605
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K062087
• 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): 06/26/2024

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: 338960
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2019
• 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