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

Catalog Number	662875
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	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after using bd facslyric¿ erroneous results were acquired.The following information was provided by the initial reporter: it was reported by the customer that absolute values trending high for cd3,cd8,cd45 trucount assay.Cx says the absolute numbers are too high for the ivd cd3,cd8,cd45 trucount assay.Cx has tried a new lot of csandt beads and tried going back to the old csandt bead lot and finds the absolute numbers for this test is still trending upward.Cx has been using calibrated pipettes and also trying reverse pipette techniques.Cx uses this instrument for clinical samples but the trends were noticed on normal controls.Cx says this issue may of impacted some clinical samples.Absolute values trending high for cd3,cd8,cd45 trucount assay.
Additional Manufacturer Narrative
G.7: multiple pma/510k# : k201814.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office (b)(6).G.1 - manufacturing site contact - (b)(4).H.6 investigation summary: based on the investigation results, the complaint was confirmed and the potential cause of the customer experiencing erroneous results on the facslyric was determined to be a worn-out pipette.The customer replaced the pipette during troubleshooting and the instrument is functioning as expected.Customer confirmed that there was no patient impact.The safety risk of this hazard has been identified to be within the acceptable level.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 after using bd facslyric¿ erroneous results were acquired.The following information was provided by the initial reporter: it was reported by the customer that absolute values trending high for cd3,cd8,cd45 trucount assay.Cx says the absolute numbers are too high for the ivd cd3,cd8,cd45 trucount assay.Cx has tried a new lot of csandt beads and tried going back to the old csandt bead lot and finds the absolute numbers for this test is still trending upward.Cx has been using calibrated pipettes and also trying reverse pipette techniques.Cx uses this instrument for clinical samples but the trends were noticed on normal controls.Cx says this issue may of impacted some clinical samples.Absolute values trending high for cd3,cd8,cd45 trucount assay.

• Brand Name: BD FACSLYRIC¿
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES
• 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: 18066338
• Report Number: 2916837-2023-00213
• Device Sequence Number: 12655554
• Product Code: OYE
• UDI-Device Identifier: 00382906628756
• UDI-Public: (01)00382906628756
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170974
• 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
• Report Date (Section B): 06/26/2024

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: 662875
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2019
• 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