MAUDE Adverse Event Report: BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number AU681-02E, CHEMISTRY ANALYZER AU680 WITH ISE AND PROSERVICE,

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 06/09/2018

Event Type  Injury  

Manufacturer Narrative

A follow-up with the customer confirmed no issues with the analyzer.The employee was not wearing safety goggles/eye protection at the time of the incident.The employee returned to work after the emergency room visit and continued with normal work schedule.(b)(6).

Event Description

Customer reported an employee was exposed to ion selective electrode (ise) cleaning solution on the eye when performing daily maintenance on their au680 chemistry analyzer.After the employee washed their eyes for 15 minutes according to the msds, the employee was sent to emergency room (er) for medical attention and was prescribed erythromycin.

• Brand Name: AU680 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: 7616890
• MDR Text Key: 111615950
• Report Number: 9612296-2018-01006
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 14987666535646
• UDI-Public: (01)14987666535646(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961274
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AU681-02E, CHEMISTRY ANALYZER AU680 WITH ISE AND PROSERVICE,
• Device Catalogue Number: N3663000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/09/2018
• Date Manufacturer Received: 06/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other