MAUDE Adverse Event Report: BECKMAN COULTER CLEARLLAB 10C M2 CELL TUBE; FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.

Model Number	CLEARLLAB 10C M2 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	09/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d2, product code - oye was entered which is a secondary code for the clearllab 10c b cell tubes, the primary code is pwd, which was not an available option for this field.There were intermittent unexpected cd19+ events appearing in the wrong place when running clearllab 10c b cell tube and clearllab 10c m2 cell tube.Specimens with questionable or abnormal scatter patterns were rerun with an alternate method.The bec field application specialist found that the issue was not occuring on all samples run and that other applications were running without issue.Troubleshooting performed by the customer and the field applications specialist indicates that there may be specimen related impact in the performance of the analysis.Per the product safety reference (prs) for clearllab reagent and clearllab 10c panels: these reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the specifically identified neoplasms.Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.The selected reagents are intended to evaluate the immunophenotypic profiles of various cell populations as indicated for specific medical indications in accordance with the intended use of the product.They are not intended to provide independent determination for the presence or absence of specific disease but rather provide the clinical practitioner with appropriate flow cytometric information that in combination with other modalities (cytogenetics, morphological evaluation, immunohistochemistry, molecular studies, patient history and physical examination) can be used to reach a clinical diagnosis.Labeling: per the navios instructions for use (pn: a96247ae), the user is instructed to and/or advised of: there is a risk of reporting incorrect results.Data displays used to arrive at the test result for light scatter patterns, antibody staining profiles, and all gates and boundaries should be reviewed by a laboratory professional when interpreting the data.If results are suspect, follow your laboratory's procedures to resolve.Per the clearllab instructions for use (pn: c00197): abnormal states of health are not always represented by abnormal percentages of certain leukocyte populations.An individual in an abnormal state of health may show the same leukocyte percentages as a healthy person.It is recommended to use test results in conjunction with clinical and other diagnostic data.Certain patients may present unique problems due to altered or very low numbers of certain cellular populations.Customer technical support (cts) provided replacement reagent tubes.The customer tested the new lot and found the issue was greatly improved.Bec internal identifier - (b)(4).Related event - (b)(4), mdr - 1061932-2023-00104.
Event or Problem Description
The customer reported unexpected cd19+ events intermittently when running clearllab on the navios ex 10 colors/3 laser flow cytometer.The customer reported that the results were not reported out of the laboratory.There was no report of death or impact to patient treatment or health.Patient results with questionable and or abnormal scatter patterns were rerun with an alternate method.The issue is not occurring on all samples.The other applications are running without issue on the same flow cytometer.The customer uses their own laboratory developed sample preparation procedure instead of the procedure in the instructions for use (ifu pn c00197).The clearlab tubes were run on the navios ex 10 colors/3 laser flow cytometer: part number: bb0910.Serial number: (b)(6).Instrument udi: (b)(4).

• Brand Name: CLEARLLAB 10C M2 CELL TUBE
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw147 avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 17877375
• Report Number: 1061932-2023-00105
• Device Sequence Number: 12556072
• Product Code: OYE
• UDI-Device Identifier: 15099590701505
• UDI-Public: (01)15099590701505(17)240524(11)230525(10)240523_02
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K183592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2023

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
• Device Model Number: CLEARLLAB 10C M2 CELL TUBE
• Device Catalogue Number: B96808
• Device Lot Number: 240523_02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown