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
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 7708047
• Report Number: 1061932-2018-01023
• Device Sequence Number: 732325
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Recall,Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: B24802
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/23/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/28/2018
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2050012-0730/2018-011-C
• Patient Sequence Number: 1