MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES BD FACSLYRIC¿ FLOW CYTOMETER; FLOW CYTOMETRIC REAGENTS AND ACCESS

Catalog Number	663518
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	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during use with bd facslyric¿ flow cytometer carryover occurred on patient samples.There was no report of patient impact.The following information was provided by the initial reporter: the customer reports that they are seeing trucount beads carrying over into subsequent samples intermittently.Also, their absolute counts when run on multiple tubes are off.Did carryover happened on patient samples? "yes" they are seeing trucount bead carry over in patient samples.
Event or Problem Description
It was reported that during use with bd facslyric¿ flow cytometer carryover occurred on patient samples.There was no report of patient impact.The following information was provided by the initial reporter: the customer reports that they are seeing trucount beads carrying over into subsequent samples intermittently.Also, their absolute counts when run on multiple tubes are off.Did carryover happened on patient samples? "yes" they are seeing trucount bead carry over in patient samples.
Additional Manufacturer Narrative
The following field has been updated with corrected information: d.4.Unique identifier (udi) #: (b)(4).The following fields have been updated with corrected information: h.6 imdrf annex b: b21.H.6 imdrf annex c: c21.H.6 imdrf annex d: d16.
Additional Manufacturer Narrative
Investigation summary: based on the investigation results, the reported issue of carryover was confirmed.The potential cause was determined to be fluidics tubing and p1 pump failures.The field service engineer (fse) investigated the issue and replaced the fluidics tubing and the p1 pump and its fitting, which resolved the issue and returned the instrument to operational status.This issue did not impact patient diagnosis or treatment and no user or patient was harmed or injured.The complaint sample was not requested to be returned because the complaint was confirmed through other elements of the investigation.Review of the device history record (dhr) review confirmed that the instrument met all the manufacturing specifications prior to release.
Event or Problem Description
It was reported that during use with bd facslyric¿ flow cytometer carryover occurred on patient samples.There was no report of patient impact.The following information was provided by the initial reporter: the customer reports that they are seeing trucount beads carrying over into subsequent samples intermittently.Also, their absolute counts when run on multiple tubes are off.Did carryover happened on patient samples? "yes" they are seeing trucount bead carry over in patient samples.

• Brand Name: BD FACSLYRIC¿ FLOW CYTOMETER
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESS
• 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: 19192684
• Report Number: 2916837-2024-00028
• Device Sequence Number: 8473828
• Product Code: OYE
• UDI-Device Identifier: 00382906635181
• UDI-Public: (01)00382906635181(11)220701
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K201814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2024

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: 663518
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 04/19/2024; 09/23/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 08/27/2024; 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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