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	09/27/2023
Type of Reportable Event	Malfunction
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.E.7.Initia reporter address: (b)(6).
Event or Problem Description
It was reported that after using bd facscanto¿ ii erroneous results were acquired.There was no patient impact nor adverse events.The following information was provided by the initial reporter: cytometer is giving rare populations and requires lack of scaling area adjustment."1.Were there erroneous results in patient samples for diagnostic testing? yes, the population was identified, but the result was not released to the patient.2.Was there any delay in treatment due to the problem? the sample was ordered to be subrogated.3.If patients were re-sampled, were there any changes or delays in treatment? the samples were subrogated and the appropriate result was released, there was no wrong treatment 4.Was there any physical harm or injury to the patient due to the problem? no".
Event or Problem Description
It was reported that after using bd facscanto¿ ii erroneous results were acquired.There was no patient impact nor adverse events.The following information was provided by the initial reporter: cytometer is giving rare populations and requires lack of scaling area adjustment."1.Were there erroneous results in patient samples for diagnostic testing? yes, the population was identified, but the result was not released to the patient.2.Was there any delay in treatment due to the problem? the sample was ordered to be subrogated.3.If patients were re-sampled, were there any changes or delays in treatment? the samples were subrogated and the appropriate result was released, there was no wrong treatment 4.Was there any physical harm or injury to the patient due to the problem? no".
Additional Manufacturer Narrative
H6.Investigation summary: based on the investigation results, the reported issue for the scaling misadjustment was confirmed.Investigation results that were performed on the indicated failure mode were the following : the potential cause of the scaling misadjustment was pmt failure.The customer reported a complaint regarding scaling misadjustment.In order to resolve the issue, the field service representative (fsr) replaced the pmt and performed a series of tests to verify the operation.After the works performed, the instrument was tested and meeting specifications.Although the instrument was used for diagnostic testing, the issue was identified and 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
• 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: 18602853
• Report Number: 2916837-2023-00239
• Device Sequence Number: 21106753
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: (01)00382903389629
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Other,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: 10/11/2023
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• 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