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	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.4.Device manufacture date: unknown.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 bd facscalibur¿ flow cytometer: 4 color erroneous results occurred and reported to the doctor.No patient treatment delay and no patient injuries were reported.The following information was provided by the initial reporter: customer reported that there was sample from one patient where cd4+ was not detected even though it was confirmed by other laboratory that these are present.At the moment it is not known where the fault lies (sample preparation, antibodies (bought from bd) or on the instrument itself, thus the case is being open for investigation purposes.The cd4 was not detected in the blood sample from one patient (but was found in the different laboratory in frankfurt).The controls were detected so customer does not understand why it happened and tries to get to the bottom of this.The doctor was informed - no treatment was affected by the issue.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: d.4.Unique identifier (udi) #: (b)(4).H.6 imdrf annex b: b21.H.6 imdrf annex c: c21.H.6 imdrf annex d: d16.
Event or Problem Description
It was reported that while using bd facscalibur¿ flow cytometer: 4 color erroneous results occurred and reported to the doctor.No patient treatment delay and no patient injuries were reported.The following information was provided by the initial reporter: customer reported that there was sample from one patient where cd4+ was not detected even though it was confirmed by other laboratory that these are present.At the moment it is not known where the fault lies (sample preparation, antibodies (bought from bd) or on the instrument itself, thus the case is being open for investigation purposes.The cd4 was not detected in the blood sample from one patient (but was found in the different laboratory in frankfurt).The controls were detected so customer does not understand why it happened and tries to get to the bottom of this.The doctor was informed - no treatment was affected by the issue.
Additional Manufacturer Narrative
Investigation summary: based on the investigation results, the reported issue of erroneous results was not confirmed.Based on an analysis of the provided customer data by applications support and technical support, no issue could be found with this instrument.There was no impact to customer or patient safety due to this event.A return sample was not requested for evaluation as no parts were replaced.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 while using bd facscalibur¿ flow cytometer: 4 color erroneous results occurred and reported to the doctor.No patient treatment delay and no patient injuries were reported.The following information was provided by the initial reporter: customer reported that there was sample from one patient where cd4+ was not detected even though it was confirmed by other laboratory that these are present.At the moment it is not known where the fault lies (sample preparation, antibodies (bought from bd) or on the instrument itself, thus the case is being open for investigation purposes.The cd4 was not detected in the blood sample from one patient (but was found in the different laboratory in frankfurt).The controls were detected so customer does not understand why it happened and tries to get to the bottom of this.The doctor was informed - no treatment was affected by the issue.

• 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: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 19346387
• Report Number: 2916837-2024-00030
• Device Sequence Number: 17812440
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: (01)00382903429752(11)111219(21)E34297501940
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K973483
• 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,Followup
• Report Date (Section B): 09/25/2024

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: 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: 04/29/2024
• Supplement Date Received by Manufacturer: 04/29/2024; 09/25/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 08/27/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2011
• 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