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	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.Initial reporter facility name: (b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that liquid leakage occurred on bd facscanto ii cytometer 4/2 system ivd and caused erroneous patient sample results.No patient treatment delay was reported.The following information was provided by the initial reporter: liquid leakage in hydraulic system.Are there erroneous on patient samples from diagnostic test? yes.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2024-00010 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that liquid leakage occurred on bd facscanto ii cytometer 4/2 system ivd and caused erroneous patient sample results.No patient treatment delay was reported.The following information was provided by the initial reporter: liquid leakage in hydraulic system are there erroneous on patient samples from diagnostic test? yes.
Additional Manufacturer Narrative
This correction report is being sent to correct the previously submitted report 2916837-2024-00010 for the following fields: type of reportable events: malfunction.
Event or Problem Description
It was reported that liquid leakage occurred on bd facscanto ii cytometer 4/2 system ivd and caused erroneous patient sample results.No patient treatment delay was reported.The following information was provided by the initial reporter: liquid leakage in hydraulic system.Are there erroneous on patient samples from diagnostic test? yes.

• 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: 18623673
• Report Number: 2916837-2024-00010
• Device Sequence Number: 14054926
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 0382903389605
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 04/03/2024

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: 01/05/2024
• Supplement Date Received by Manufacturer: 02/08/2024; 03/13/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/09/2024; 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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