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	01/23/2024
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 during use with the bd facscanto¿ ii.The following information was provided by the initial reporter: patient sample checklist: 1.Are there erroneous results on patient samples from diagnostic test? yes.2.Was there any delay of treatment due to the issue? no.3.If patient sample were redrawn, was there any change or delay of treatment? no.4.Was there any physical harm/injury to the patient due to issue? no.The customer reported the results are not as expected.The qc passed fine.The customer did several cleanings and purges, but problem persists.
Additional Manufacturer Narrative
H.6.Investigation summary: based on the investigation results, the reported issue for the system producing erroneous results was confirmed.Investigation results that were performed on the indicated failure mode were the following : the dhr was reviewed and the instrument met all the manufacturing specifications prior to release.The potential cause for the erroneous results was a faulty sheath regulator.After the replacement of this component and a laser alignment, the instrument was performing as expected.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.
Event or Problem Description
It was reported that erroneous results were observed during use with the bd facscanto¿.The following information was provided by the initial reporter: patient sample checklist: 1.Are there erroneous results on patient samples from diagnostic test? yes.2.Was there any delay of treatment due to the issue? no.3.If patient sample were redrawn, was there any change or delay of treatment? no.4.Was there any physical harm/injury to the patient due to issue? no.The customer reported the results are not as expected.The qc passed fine.The customer did several cleanings and purges, but problem persists.

• 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: 18620400
• Report Number: 2916837-2024-00009
• Device Sequence Number: 11355063
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: 00382903389629
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 03/22/2024

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: 01/23/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• 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