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

Catalog Number 6605500

Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

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

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument at the customer's site.The fse confirmed failing plt background values and found that the red blood cell (rbc) bath was defective, contributing to the issue.The fse replaced the rbc bath, which resolved the problem.The beckman coulter internal identifier for this report is (b)(4).

Event Description

The customer reported erroneous high platelet (plt) results were generated for 22 patients on a coulter ac·t diff 2 analyzer.When the samples were re-run on a different instrument, results were approximately 300 units lower, according to the customer.Controls run prior to the event were within specification; however, the customer re-ran controls after the event and controls flagged high for plt.Result printouts were provided by the customer, but corrected results were not provided for comparison.There was no change or effect to patient treatment reported in connection to the 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: laurie o'riordan ; 11800 sw 147th avenue, 32-v11; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 7367594
• MDR Text Key: 103531529
• Report Number: 1061932-2018-00006
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2007
• 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