MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR¿ FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Catalog Number	342975
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	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.4 initial reporter phone #:(b)(6).E.7 initial reporter addr 1: (b)(6).G.6 pma / 510(k)#: k923790, k973483.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 while using the bd facscalibur¿ flow cytometer that there was erroneous results.The following information was provided by the initial reporter: case related to a event rate issue; values were not normal and was due to a misconfiguration no results involved, were actually values with both samples, but were not released.Could you clarify what the "unexpected results" would be? values were not normal and was due to a misconfiguration were the unexpected results with control samples or with patient samples? no.Results were actually values with both samples, but were not released, so the patient was not treated based on the result and was not subjected to harm.If patient samples, were incorrect results obtained or used? no.Was the patient treated based on the outcome? no.Was there any harm to the patient? no.Equipment did not enable fl4 at power up, being necessary to enable it manually for calibration.However, after acquiring the samples the results showed unexpected results.
Event or Problem Description
It was reported that while using the bd facscalibur¿ flow cytometer that there was erroneous results.The following information was provided by the initial reporter: case related to a event rate issue; values were not normal and was due to a misconfiguration no results involved, were actually values with both samples, but were not released.- could you clarify what the "unexpected results" would be? values were not normal and was due to a misconfiguration - were the unexpected results with control samples or with patient samples? no results were actually values with both samples, but were not released, so the patient was not treated based on the result and was not subjected to harm.- if patient samples, were incorrect results obtained or used? no - was the patient treated based on the outcome? no - was there any harm to the patient? no equipment did not enable fl4 at power up, being necessary to enable it manually for calibration.However, after acquiring the samples the results showed unexpected results.
Additional Manufacturer Narrative
H.6: after further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2023-00147 was sent in error.It has been determined that the issue was related to a misconfiguration that was fixed and there were no errors in final results, therefore, this not considered to be a reportable malfunction.

• Brand Name: BD FACSCALIBUR¿ FLOW CYTOMETER
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17379804
• Report Number: 2916837-2023-00147
• Device Sequence Number: 12244577
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K923790
• 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): 09/21/2023

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: 342975
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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