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

Model Number AU5800-10, CHEMISTRY ANALYZER AU5800

Device Problem Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

No parts were replaced.There is insufficient evidence of a system or reagent malfunction.The issue occurred due to use error.No further issues were reported from the field service engineer.(b)(4).

Event Description

The fse strained his right forearm while disassembling tubing on the au5800 clinical chemistry analyzer.The fse felt a shooting hot pain in right forearm and was unable to lift items without pain.

• Brand Name: AU5800 CLINICAL CHEMISTRY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• 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: david davis ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 8819804
• MDR Text Key: 152018293
• Report Number: 9612296-2019-01326
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 14987666541296
• UDI-Public: (01)14987666541296(11)NO-DATA
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AU5800-10, CHEMISTRY ANALYZER AU5800
• Device Catalogue Number: B23279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/21/2019
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2016
• 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