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	03/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2017 the field service engineer (fse) was at the customer site and observed there was an obstruction in the platelet pathway of the dxh800 instrument.The fse removed the obstruction in the platelet pathway to resolve the issue.The rbc bath and associated tubing were also replaced as well as the sweep flow spool.The cause of the high platelet results is attributed to an obstruction in the platelet pathway.Patient information was not provided by the customer.Beckman coulter is conducting a retrospective review of its global service records, to ensure that the records had been adequately evaluated for potential complaint information and any warranted follow-up action, including mdr reporting.  this mdr report is a result of that retrospective review.  an improvement for plt flagging was developed and released as a part of a software update to the dxh800 that is designated v3.2.1 on (b)(6) 2017; approximately 11.5% of the worldwide product installed base has been upgraded as of (b)(6) 2018.Due to an increase in the number of complaints received related to unflagged erroneously high plt patient results released from the lab, bec anticipates that a field action will be warranted.The anticipated field action will include a software patch for the improvement for the plt flagging component of v3.2.1, which will expedite installation of this improvement for the rest of the installed base.(b)(4).
Event or Problem Description
The customer reported that their unicel dxh 800 coulter cellular analysis system generated false high platelet (plt) results.There was no report of change or effect to patient treatment in connection with the reported event.Patient data was not provided by the customer for this event.
Additional Manufacturer Narrative
Follow up 01: an improvement for plt flagging was developed and released as a part of a software update to the dxh800 that is designated v3.2.1 on 22-dec-2017; approximately 11.5% of the worldwide product installed base has been upgraded as of 13-jul-2018.Due to an increase in the number of complaints received related to unflagged erroneously high plt patient results released from the lab, bec has determined that a field action is warranted.Field action (fa-33718) was approved on 30-jul-2018.The field action includes a software patch for the improvement for the plt flagging component of v3.2.1, which will expedite installation of this improvement for rest of the installed base.Section h2 - additional information has been selected.Section h7 - recall, notification and modification have been selected.Section h9 - number has been updated to reflect the respective information for this event.Additional information: the recall (fa-33718) includes notification to the customer and correction of the issue via software update.Bec internal identifier: (b)(4).

• 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: 7730956
• Report Number: 1061932-2018-01014
• Device Sequence Number: 1588449
• 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,Notification,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: 03/26/2017
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 07/30/2018
• 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