MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2018, the field service engineer (fse) was at the customer site and reviewed some of the patient sample data in question.He confirmed there was an elevated plt issue.The instrument had not been in use since the problem was identified in the afternoon of (b)(6) 2018.The fse checked that the sweepflow spool had not de-primed and performed the sweepflow prime procedure.The fse then ran patient samples and verified that all plt aperture results matched.Service activity performed was verified to meet the specified requirements per established procedures.The failure mode is unknown.The cause of the erroneous results could not be determined with the information available.Patient information was not provided by the customer for this event.(b)(4).

Event Description

The customer reported that their unicel dxh 800 coulter cellular analysis system was generating high platelet (plt) results on patient samples which were significantly lower when repeated on the other unit in the laboratory.Customer stated that erroneous patient results (22 total) that were reported out were corrected and that they do not believe there was any change to patient treatment.The patient data that was provided by the customer are from the lis files.Customer does not print patient results but spot-checked a few patient results on the instrument and found the results erroneous results were not flagged by the instrument.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• 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 ; 3053802874
• MDR Report Key: 7708047
• MDR Text Key: 114712929
• Report Number: 1061932-2018-01023
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: B24802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2050012-0730/2018-011-C
• Patient Sequence Number: 1