MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC·T DIFF ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number	6706366
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) evaluated the instrument at the customer's site.The fse found that the tubing through valve lv8 was defective, causing the leak.The fse replaced the tubing, resolving the leak.The repairs were verified per established service procedures.The beckman coulter internal identifier for this report is (b)(6).
Event or Problem Description
The customer reported less than 1 ml of uncontained fluid leaked from the probe in a coulter ac t diff analyzer onto the counter during normal instrument operation.There were vacuum error messages reported by the customer at the time of the event.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat, goggles and gloves at the time of the event and there was no report of injury or biohazard exposure to open wounds or mucous membranes.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection to the event.There was no impact to patient results and controls.

• Brand Name: COULTER AC·T DIFF ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• MDR Report Key: 6012497
• Report Number: 1061932-2016-00885
• Device Sequence Number: 10783398
• Product Code: GKZ
• UDI-Device Identifier: 15099590264734
• UDI-Public: (01)15099590264734
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K973634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6706366
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Initial Report FDA Received Date: 10/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1