MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number TN,DXH 600 HEMATOLOGY SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fracture, Arm (2351)

Event Date 02/04/2019

Event Type  Injury  

Manufacturer Narrative

Service was not sent to the customer site for this event.The information available does not indicate that the injury was a direct result of an instrument malfunction.The operator is back to work part time; her arm has been immobilized to allow for proper healing.Bec internal identifier - (b)(4).

Event Description

The cord of the barcode reader on the customer's dxh600 hematology instrument became entangled around the operator's ankle as she was turning away from the instrument.The operator fell and broke her arm.There was no report of erroneous results being generated by the instrument.There was no patient impact as a result of this event.

• Brand Name: UNICEL DXH 600 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: 8401504
• MDR Text Key: 138158140
• Report Number: 1061932-2019-01336
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590192242
• UDI-Public: (01)15099590192242(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TN,DXH 600 HEMATOLOGY SYSTEM
• Device Catalogue Number: 823858
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/04/2019
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other