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

Catalog Number	6706366
Medical Device Problem Codes	Fluid/Blood Leak (1250); Missing Test Results (3267)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) evaluated the instrument and found that the wbc waste line was partially clogged attributing to the leak and normal and high control failures reported by the customer.The fse removed the clog, the instrument was verified with no further issues observed and all parameters recovering within specifications the fse performed verification of the instrument to meet the specified requirements per established service procedures.(b)(4).
Event or Problem Description
The customer reported an uncontained fluid leak approximately 1ml in volume and normal and high control failures on their coulter ac·t diff analyzer.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat, gloves and eye protection at the time of the event.There was no report of injury or biohazard exposure to open wounds or mucous membranes.

• 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: 6062101
• Report Number: 1061932-2016-00931
• Device Sequence Number: 550062
• Product Code: GKZ
• UDI-Device Identifier: 15099590264734
• UDI-Public: (01)15099590264734
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/04/2016

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: 10/04/2016
• Initial Report FDA Received Date: 10/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1