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

Catalog Number 6605500

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Output below Specifications (3004)

Patient Problem Not Applicable (3189)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument on 09/11/2015.The fse found that the tubing became disconnected from the rinse pump and caused a leak.The fse trimmed and reattached the tubing at the rinse pump, which repaired the leak.The repairs were verified by established procedures.(b)(4).

Event Description

The customer reported the granulocytes (gr) recovered low out of specification on all three levels of 4c controls when cycled on the coulter act diff 2 analyzer.Erroneous patient results were not reported outside of the laboratory and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

The device code was not provided in the initial report, and has been added in this follow-up report.The information provided in the initial report was found to be incorrect; the corrected information is provided below: a field service engineer (fse) evaluated the instrument on 09/28/2015.The fse confirmed the gr % was recovering low out of specification on the 4c controls.The fse replaced the white blood cell (wbc) bath and adjusted the clog detection due to a possible restriction, resolving the issue.The customer was sent a new set of control samples.The fse stated that the prior controls and new controls sent recovered within specification following onsite service.The repairs were verified per established service procedures.

• Brand Name: COULTER ACT 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 FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-s08; miami, FL 33196 ; 3053802031
• MDR Report Key: 5171738
• MDR Text Key: 29343158
• Report Number: 1061932-2015-01612
• 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,Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• 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
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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