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

Model Number TN,DXH 800 HEMATOLOGY SYSTEM

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018, the field service engineer was at the customer site and observed that during troubleshooting controls were also running high in addition to patient samples.The fse replaced the rbc bath and ran startup, controls, and did a comparative measurement to the other dxh instruments in the lab and results were consistent.The rbc bath was replaced to resolve the reported issue.Patient information was not provided by the customer.(b)(4).

Event Description

The customer reported that their unicel dxh 800 coulter cellular analysis system was generating high platelet results.Erroneous results were not reported out of the lab.There was no change or effect to patient treatment as a result of this event.Patient data was not provided by the customer.

Manufacturer Narrative

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.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
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 7717060
• MDR Text Key: 114942455
• Report Number: 1061932-2018-01030
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (y/n): N
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Modification/Adjustment
• 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: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TN,DXH 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/25/2018
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2050012-0730/2018-011-C
• Patient Sequence Number: 1