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

Model Number 800

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

On 27 jul 2018, the field service engineer (fse) was at the customer site and observed that the dxh800 instrument had high platelets at startup.The fse replaced the rbc to resolve the reported event.The assignable cause of the reported event was the rbc bath.(b)(4).

Event Description

The customer reported that platelet (plt) results for patients samples are running erroneously high on their unicel dxh 800 coulter cellular analysis system.There was no change to patient treatment reported as a result of this event.The customer did not provide patient data.

• 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
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 7920641
• MDR Text Key: 122657562
• Report Number: 1061932-2018-01046
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2018

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
• Device Operator: Health Professional
• Device Model Number: 800
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/27/2018
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1