MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. CLEARLLAB 10C B CELL TUBE; FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.

Model Number	CLEARLLAB 10C B CELL TUBE
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	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code - navios flow cytometry instrument code 'oye' was populated in field because the correct product code of 'pwd' would not populate in the respective field labeling: per the clearllab system guide (pn: c24688) the user is instructed and/or advised that: due to the nature of multi-color flow cytometry and specimen variability, some antigen/fluorescent marker combinations exhibit spreading, which increases signal spillover into other channels.Trained operators must determine that the fluorescent compensation and gating are appropriate.All data plots and histograms must be reviewed before results are reported to ensure analysis was performed correctly.A review of all data plots for the presence of the expected staining patterns is recommended for all samples.Bec internal identifier (b)(4).
Event or Problem Description
We are using clearllab 10c for characterization b cells leukemia.Cd38 marker is detected in the channel apc-af700.When we setup the compensation with the parameters defined by manufactur the signal in cd38 apc af700 is so high and the events are shown in the extrem e right axis.We detect a spectral spillover because the plasma cells are positive in the next channel with the marker cd20 apc af750.Erroneous patient results were generated but were not reported out of the laboratory.There was no change or effect to patient treatment in connection to the event.The customer considered the results to be erroneous and repeated the tests using liquid reagent to obtain acceptable results.

• Brand Name: CLEARLLAB 10C B CELL TUBE
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills, co. clare ; EI
• Manufacturer (Section G): BECKMAN COULTER; 130 ave de lattre de tassigny; bp 177, cedex 9 bouches-du-rho; marseille 13276 ; FR 13276
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 13902717
• Report Number: 1061932-2022-00020
• Device Sequence Number: 4596316
• Product Code: OYE
• UDI-Device Identifier: 15099590701475
• UDI-Public: (01)15099590701475(17)211109(11)NO-DATA(10)081120_44
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K183592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2022

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: Health Professional
• Device Model Number: CLEARLLAB 10C B CELL TUBE
• Device Catalogue Number: B96805
• Device Lot Number: 081120_44
• 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: 02/23/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown