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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 12/28/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument.The fse found that valve lv15 was defective.The fse replaced the valve, which repaired the leak.(b)(4).

Event Description

The customer reported a leak from the baths of the coulter act diff 2 instrument.The volume of the leak was about 20 ml and was not contained within the instrument.The customer stated that three patient results were impacted by the leak.The customer did not provide the impacted results.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 gloves, goggles and a laboratory coat 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 2 ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-s08; miami 33196 ; 3053802031
• MDR Report Key: 6273464
• MDR Text Key: 65609912
• Report Number: 1061932-2017-00001
• 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: 12/28/2016

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 Model Number: N/A
• Device Catalogue Number: 6605500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1