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

Model Number AC*T DIFF 2

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

On 18-jun-2018 the field service engineer (fse) was at the customer site and observed that the coulter ac·t diff 2 analyzer was generating high platelet results with electrical noise on the plt histogram.The fse replaced the vacuum isolation chamber (vic) which eliminated the electrical crosstalk and resolved the noise problem.Service activity performed was verified to meet the specified requirements per established procedures.Results meet published performance specifications.The cause of the high plt on qc and patient samples was a defective vacuum isolator chamber.Patient information was not provided by the customer.Bec internal identifier - (b)(4).

Event Description

The customer reported having an ongoing issue with erroneously high platelet (plt) for qc and patient samples on their coulter ac·t diff 2 analyzer.Erroneous results were not reported outside of the laboratory.There was no change to patient treatment as a result of this event.Patient and qc data was not provided by the customer.

• 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 2031
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 7684078
• MDR Text Key: 113892792
• Report Number: 1061932-2018-01025
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• 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: 07/12/2018

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: AC*T DIFF 2
• Device Catalogue Number: 6605500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/15/2018
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1