MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO¿ II FLOW CYTOMETER; 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	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with bd facscanto¿ ii flow cytometer erroneous results were reported to a clinician.There was no patient impact.The following information was provided by the initial reporter: sample will be aspirated very fast.1.Did this cause erroneous results on patient samples for diagnostic testing? yes 2.Was an erroneous laboratory result from the bdb product reported to a clinician? yes 3.Was there any change or delay of treatment due to the issue? no because they will rerun the sample on the same day and no delay for generating the correct results on time.
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 field has been updated with corrected information: h.6 imdrf annex g: g04069 h.6 investigation summary: based on the investigation results, the reported issue of samples aspirating very quickly 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 the customer experiencing samples aspirating very quickly linked to tubing in the fluidic system.Tubing 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.
Event or Problem Description
It was reported that during use with bd facscanto¿ ii flow cytometer erroneous results were reported to a clinician.There was no patient impact.The following information was provided by the initial reporter: (b)(6).1.Did this cause erroneous results on patient samples for diagnostic testing? yes 2.Was an erroneous laboratory result from the bdb product reported to a clinician? yes 3.Was there any change or delay of treatment due to the issue? no because they will rerun the sample on the same day and no delay for generating the correct results on time.

• Brand Name: BD FACSCANTO¿ II FLOW CYTOMETER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 155 north mccarthy boulevard; milpitas CA 95035
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 155 north mccarthy boulevard; milpitas CA 95035
• Manufacturer Contact: fahmy razak - mdr ; 155 north mccarthy boulevard; milpitas, CA 95035 ; 8772328995
• MDR Report Key: 23778292
• Report Number: 3027394506-2025-00047
• Device Sequence Number: 18656373
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: (01)00382903389605(11)120322
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/10/2026

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: 11/28/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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