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

Model Number	TN,DXH 600 HEMATOLOGY SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fracture, Arm (2351)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 8401504
• Report Number: 1061932-2019-01336
• Device Sequence Number: 1976078
• Product Code: GKZ
• UDI-Device Identifier: 15099590192242
• UDI-Public: (01)15099590192242(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TN,DXH 600 HEMATOLOGY SYSTEM
• Device Catalogue Number: 823858
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 03/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other