MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC·T DIFF ANALYZER

Catalog Number 6706366

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on (b)(4) 2015 and found that the customer had corrected the issue previous to his arrival.The customer replaced peristaltic pump tubing from the waste as there was a hole found in it.The repairs were verified per established procedures by the fse.(b)(4).

Event Description

The customer reported that there was a diluent error on the screen of the coulter ac·t diff analyzer.In addition the customer reported that there was an uncontained, clear fluid leak of approximately 1ml from the instrument during startup.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.There was no impact to patient results and controls.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat, gloves, and goggles at the time of the event and there was no report of injury or biohazard exposure to open wounds or mucous membranes.

• Brand Name: COULTER AC·T DIFF ANALYZER
• Type of Device: COULTER AC·T DIFF ANALYZER
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 5316377
• MDR Text Key: 34081171
• Report Number: 1061932-2015-01863
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973634
• 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: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 6706366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2008
• 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