MAUDE Adverse Event Report: BECKMAN COULTER AU5800 CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number AU5800-10, WIN7, CHEMISTRY ANALYZER AU5800

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem Fall (1848)

Event Date 03/27/2021

Event Type  Injury  

Manufacturer Narrative

The customer reported antifoam spilled on the night of (b)(6) 2021.The spilled antifoam was quickly contained and wiped; however, it left a slick spot on the floor.On the night of (b)(6) 2021, someone slipped on the slick spot and fell.The individual was sent to the emergency room (er) for medical attention.Customer stated the individual was excused from work for a few weeks.No further details were provided.Beckman coulter customer technical support (cts) advised the customer the material safety data sheet (msds) states to absorb spilled material with an appropriate inert, non-flammable absorbent and dispose according to local regulations.Additionally, cts advised the customer to try cleaning with some soap and water.The available information does not reasonably suggest that the instrument or reagent malfunctioned.The failure mode is spilled antifoam that was not cleaned up according to msds.Customer was satisfied with the support and had no further questions.Age, weight, and ethnicity: information not provided by customer.The beckman coulter internal identifier is (b)(4).

Event Description

The customer reported an individual slipped and fell due to spilled antifoam.There were no reports of erroneous results or exposure related to this event.The individual was sent to the emergency room (er) for medical attention.Customer stated the individual was excused from work for a few weeks.No further information was provided regarding any treatment for the individual or the extent of the injury.

• Brand Name: AU5800 CHEMISTRY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino; nagaizumi-cho sunto-gun; schizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 11667231
• MDR Text Key: 245441573
• Report Number: 9612296-2021-00136
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 14987666543016
• UDI-Public: (01)14987666543016(11)170101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112412
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AU5800-10, WIN7, CHEMISTRY ANALYZER AU5800
• Device Catalogue Number: B96697
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/29/2021
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other