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

Catalog Number	338962
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	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.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 erroneous results were observed on patient samples during use with the bd facscanto¿ ii.The following information was provided by the initial reporter: 1.Were erroneous results observed on patient samples? 2.Whether carryover happened on patient samples? the customer reported it takes twice as long to acquire a sample and the values are about twice too high.The flow rate is too slow in any flow rate mode and event rate too high.The populations look the same, no debris visible, there are more events.The threshold is ok and the samples are diluted like before the issue.
Event or Problem Description
It was reported that erroneous results were observed on patient samples during use with the bd facscanto¿ ii.The following information was provided by the initial reporter: 1.Were erroneous results observed on patient samples? yes 2.Whether carryover happened on patient samples? no.
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:(b)(6)- mdr manufacturing office contact: (b)(6) - mdr h.6: based on the complaint trend, defect trend, dhr review, risk analysis, and service activity review, the reported 'issue with flowrate' was not confirmed, and the potential cause of the issue could not be determined.The customer reported a complaint regarding flow rate issue.To resolve the issue, fse performed trucount beads test and found that flow rate is within specifications and instrument is functioning as intended.The safety risk of this hazard is deemed to be within acceptable criteria.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored to determine if further action is needed.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 17796011
• Report Number: 2916837-2023-00185
• Device Sequence Number: 14009716
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: 00382903389629
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

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: 09/13/2023
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 03/20/2024
• 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