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	Test Result (2695)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was at the customer site on 3 feb 2017 and observed that there were inconsistent platelet readings generated by the dxh800 instrument.The fse found a few loose connections on the wbc (white blood count) bath causing issues with the sweep flow.The connections were secured and the cbc (complete blood count) module was primed.Repeatability passed after the procedure.The repairs were verified per established procedures.The failure mode is attributed to loose connections at the wbc bath.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 un-flagged 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.Section a - patient information was not provided by the customer.(b)(4).
Event or Problem Description
The customer reported inconsistent platelet (plt) results being generated by their unicel dxh 800 coulter cellular analysis system.There was no report of erroneous results reported out of the lab from the provided information.There was no report of impact to patient treatment from the information provided.Instrument printouts of patient results or controls were not provided 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 (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 has determined that a field action is warranted.Field action (fa-33718) was approved on (b)(6)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 - case(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: 7726931
• Report Number: 1061932-2018-01006
• Device Sequence Number: 904031
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/03/2017
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 07/27/2018
• 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