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 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015, the customer performed some troubleshooting to resolve the problems.For the aperture alerts and voteouts the customer was told to bleach the wbc count line and then was told to follow the procedure to adjust the aperture voltage ratio.It is unclear whether this aperture voltage ratio was changed due to the bleaching or if the instrument had the setting prior to troubleshooting.For the leak the customer was told to clean the probe wash block insert and shift tubing in valve lv8.After these steps in troubleshooting the customer reported that the instrument stopped leaking and there were no more alerts or voteouts.The probe leak was caused by poor scavenging of the probe wash.Cleaning the block and moving the in line pinch tubing cleared the restriction.The aperture alert/voteouts are most likely due to a clog in the aperture.Aperture targets can shift as the aperture and electrode wear.Setting the wbc target based on current data will prevent the problem from recurring.The customer technical support specialist who took this call provided additional information about the causes of the problems through email.The repairs were verified per established procedures.(b)(4).

Event Description

The customer reported aperture alerts, voteouts a contained leak of volume from the probe wash inside the coulter act diff 2 analyzer.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) 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: 5333307
• MDR Text Key: 34647427
• Report Number: 1061932-2015-01809
• 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: 12/08/2015

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: 12/08/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2003
• 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