MAUDE Adverse Event Report: BECKMAN COULTER MISHIMA AU480 CLINICAL CHEMISTRY ANALYSER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number AU481-02E, CHEMISTRY ANALYZER AU480 WITH ISE AND PROSERVICE,

Device Problem Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

The provided information does not reasonably suggest a system malfunction.The cause of the event is use error as the customer failed to follow the instrument label warnings.After injuring hand and visiting the employee services, the customer received a (b)(6) shot, antiviral medication, and blood work was performed as a precautionary measure.The customer confirmed that no medical leave was taken and he has returned to work in the laboratory.(b)(6).

Event Description

The customer, (b)(6), stated that while bending over to pick up an item from the floor, he placed his left hand on the au480 chemistry analyzer for stabilzation.While bending down the sample probe came down on his ring finger and punctured it.The customer gave verbal confirmation that the sample probe was performing within normal parameters when incident occurred.The customer stated a bandage was not needed, and he went to employee services to have the injury evaluated.

• Brand Name: AU480 CLINICAL CHEMISTRY ANALYSER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER MISHIMA; 454-32 higashino; nagaizumi-cho sunto-gun; schizuoka JP-NO TA 4; JA JP-NOTA 41
• 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: 7589326
• MDR Text Key: 110703484
• Report Number: 9612296-2018-01002
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 14987666535554
• UDI-Public: (01)14987666535554(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981743
• 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: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AU481-02E, CHEMISTRY ANALYZER AU480 WITH ISE AND PROSERVICE,
• Device Catalogue Number: N3660200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/01/2018
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other