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

Catalog Number 6605500

Device Problems Intermittent Continuity (1121); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2014

Event Type  malfunction  

Event Description

The customer reported a leak from a coulter act diff 2 analyzer.The customer estimated the volume of the leak was a few drops and was not contained within the instrument.In addition, the instrument was generating intermittent hemoglobin (hgb) values and white blood cell (wbc) flags.The instrument operator was wearing gloves, goggles, and a lab coat at the time of the leak.There were no reports of biohazard exposure to the leak.There were no erroneous results generated and patient treatment was not impacted in connection with this event.

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to evaluate the instrument.The fse did not observe an active leak, but did observe hgb background failures and intermittent wbc flags.To resolve the hgb issue, the fse replaced the lamp.To resolve the flags, the fse made adjustments to the red blood cell (rbc) and wbc baths and ran clog detection calibration.Repairs were verified per established procedures.(b)(4).

• Brand Name: COULTER ACT 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: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 4092483
• MDR Text Key: 20752811
• Report Number: 1061932-2014-02221
• 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 Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/19/2014

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
• Other Device ID Number: SW VERSION 2.01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2008
• 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