MAUDE Adverse Event Report: BECKMAN COULTER FC 500 MPL FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Model Number UPS (CXP)

Device Problems Inadequate or Insufficient Training (1643); Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 01/18/2018

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2018 the customer reported that certain cd markers showed low values and the fl2 and fl3 boards on the fc500 may be faulty.The customer requested a field service engineer (fse) to go on site and check them.The field applications support (fas) specialist went on site and reanalyzed a normal sample and noted that the voltages on the fl2 and fl3 markers in the tricolor cd5fitc/cd10pe/cd19ecd panel were low and over compensated potentially accounting for the customer's observation.The fas noted that the customer was using the incorrect instrument settings (voltages and compensation values) for the application and adjusted voltages and compensation values to better fit the application.With these settings corrected the fas was able to obtain correct results.On (b)(6) 2018 shortly before the reported date of contact ((b)(6) 2018) the customer ran a patient bone marrow sample utilizing cd5/cd10/cd19 for a lymphocytic cll/all analysis.The laboratory was running a laboratory configured assay utilizing cd5fitc/cd10pe/cd19ecd.The failure of the fl3 tarpon board impacted the cd19ecd signal causing a false negative result on that channel and incorrect color compensation values for the fl2 channel.The discrepancy between microscope slide results and the flow cytometry results caused the rejection of the sample by the laboratory.The slide smear showed 77% lymphoblasts while the flow cytometry data indicated 7% lymphoblasts.The sample was redrawn by the physician and was sent to a third party lab for analysis.Bec became aware of the sample being redrawn through email communications between the fas and the laboratory on (b)(6) 2018.This information was as a result of an inquiry by this investigator to confirm that the sample had or had not been redrawn.Through conference call communications with the fas is was learned that the laboratory does not run flow-set as part of the instrument qc.In addition the laboratory only runs immuno-trol normal at a frequency of once a month.This is not recommended as normal laboratory practice.No application specific qc is being performed for the cd5/cd10/cd19 application.This is also not recommended laboratory practice.While on site on (b)(4) 2018 the fse observed that the fl3 channel tarpon amp and signal conditioner board had failed.The fse replaced the board.This malfunction was unrelated to the incorrect settings issue.Labeling: fc500 cxp ifu pn 624923bf, section 4.3.9 states: "risk of reporting incorrect results.Data displays for light scatter patterns, antibody staining profiles, and all gates and boundaries used to arrive at the test result should be reviewed by a laboratory professional when interpreting the data." fc500 cxp ifu pn624923b, chapter 3, quality control/daily qc indicates that daily qc procedures must be performed and pass before running samples.Patient information was not provided by customer.Bec internal identifier - (b)(4).

Event Description

The customer observed and issue with the cd19ecd value on a bone marrow sample while "usine" their fc 500 mpl flow cytometer.The discrepancy between microscope slide results and the flow cytometry results caused the lab to reject the sample for analysis.This resulted in the physician having to redraw the sample.The physician then had it analyzed at a third party laboratory.As per the field applications support (fas) specialist, the customer had the instrument voltage and compensation settings that resulted in incorrect gating and questionable results for the sample.After correcting the instrument settings, the fas was able to obtain correct results.The fas also noted that the user was not following the ifu in that they were not running standardizations or controls as indicated in the ifu.

• Brand Name: FC 500 MPL FLOW CYTOMETER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031 ; 3107520824
• MDR Report Key: 8010403
• MDR Text Key: 125185886
• Report Number: 1061932-2018-00041
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590572839
• UDI-Public: (01)15099590572839(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K071681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UPS (CXP)
• Device Catalogue Number: 626553
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other