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

Model Number	AC*T DIFF 2
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 7684078
• Report Number: 1061932-2018-01025
• Device Sequence Number: 19220839
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K990352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: AC*T DIFF 2
• Device Catalogue Number: 6605500
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/15/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/12/2018
• Patient Sequence Number: 1