MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC·T DIFF 2 ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6605500

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the analyzer on 10/14/2016 and confirmed a leak at the end of the probe, caused by a blockage at the probe wipe rise block.Additionally, and unrelated to the leak, the hemoglobin lamp was worn and the analyzer alerted to hemoglobin voltage high errors.The fse replaced the probe wipe rinse block to correct the probe leaking issue, and also replaced and adjusted the hemoglobin lamp to service specifications.

Event Description

A customer reported a leak of less than 2 ml of fluid from the probe of a coulter ac·t diff 2 analyzer; additionally, hemoglobin voltage high errors were recovered.The operator was wearing personal protective equipment (ppe), consisting of gloves, goggles and a laboratory coat at the time the leak was observed.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

• Brand Name: COULTER AC·T DIFF 2 ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 6084012
• MDR Text Key: 59343716
• Report Number: 1061932-2016-00901
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990352
• 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: 10/13/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 6605500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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