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

Model Number	TN,DXH 800 HEMATOLOGY SYSTEM
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation codes - method, result, and conclusion codes updated.The field service engineer (fse) inspected the instrument, did not identify any specific failure, and was unable to replicate the reported issue.Per review of the data provided by technical support on 31-oct-2019, all latron, start up, and control data were within specifications.Technical support recommended the instrument have the latron nrbc al2 whole blood calibration procedure done because the latron calibration values were within specification but were on the high side.The fse went onsite to perform nrbc and latron calibration on 12-nov-2019.He performed the recommend calibration successfully and provided the calibration data.Review of the data could not confirm an instrument malfunction.A cause for the erroneous unflagged erroneous could not be confirmed.The erroneous un-flagged erroneous results could not be confirmed by the fse.Evidence provided does not allow to confirm if erroneous results were generated or identify a conclusive failure mode.Bec internal identifier - (b)(4).
Additional Manufacturer Narrative
Raw data and additional information regarding the results and patient outcome has been requested.This is an ongoing investigation and an update will be provided when new information becomes available.Bec internal identifier: case (b)(4).
Event or Problem Description
The customer reported that multiple erroneous high platelet (plt) results were generated by their unicel dxh 800 coulter cellular analysis instrument.The customer stated that there were both flagged an unflagged results.Additional information has been requested, with the current information available it is not known how many patients were affected by this event.The customer reported that some results had been released by the time she became aware of this issue.Some of the patients had their results corrected.There was no report of impact to patient or change in patient treatment connected to this event.

• 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
• MDR Report Key: 9241434
• Report Number: 1061932-2019-01859
• Device Sequence Number: 1564831
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)170120
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 12/09/2019
• Patient Sequence Number: 1