MAUDE Adverse Event Report: BECKMAN COULTER COULTER DXH DILUENT; DILUENT, BLOOD CELL

Model Number	628017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no instrument malfunction in this event.The available information states the distributor, movianto, delivery driver accidentally dropped a pallet of diluent on customer¿ foot while the customer was signing for the delivery.There was no indication the pallet was improperly loaded.This case is being managed by local logistics and movianto, who was the third party transport provider at the time of this incident.The cause of the event was use error.The delivery driver of the third party transportation company accidentally dropped a pallet of dxh diluent on the customer's foot.The information provided reflects that the diluent was not malfunctioning or direct cause of the reported event.In an abundance of caution beckman coulter is reporting the event.Bec internal identifier for this report is (b)(4).
Event or Problem Description
The customer reported that while signing reagent delivery receipt, the delivery driver from movianto accidentally dropped a pallet of dxh diluent 10l on their (customer¿s) foot.The customer went to urgent care where an x-ray and physical assessment were performed.The x-ray indicated no broken bones, but possible ¿ligament and tendon damage¿ was documented.The attending physician prescribed anti-inflammatory and pain medication and instructed the customer see her gp (general practitioner) for any concerns or if pain continues.
Additional Manufacturer Narrative
Follow up 01: internal bec identifier - (b)(4).

• Brand Name: COULTER DXH DILUENT
• Common Device Name: DILUENT, BLOOD CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 9406329
• Report Number: 1061932-2019-01900
• Device Sequence Number: 14030020
• Product Code: GKZ
• UDI-Device Identifier: 15099590233686
• UDI-Public: (01)15099590233686(17)210414(11)NO-DATA(10)095314K
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K081930
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 628017
• Device Catalogue Number: 628017
• Device Lot Number: 095314K
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other