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

Model Number	diff 2
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(4) 2018, the field service engineer was at the customer site and observed that platelet results were high on patient samples but not on background or controls.After replacing several components that did not resolve the issue, the fse found that replacing the probe corrected the problem and platelet results had dropped to the correct values.The fse verified the repair as per established procedures.Results met published performance specifications.The erroneous high plt results were attributed to a faulty probe.Section a - patient information was not provided by the customer.Internal bec identifier - (b)(4).
Event or Problem Description
Customer reported that the platelet (plt) results were intermittently erroneously high while during patient sample runs on their coulter ac·t diff 2 analyzer.There was no report of change or effect to patient treatment as a results of this event.Patient 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: 7728327
• Report Number: 1061932-2018-01031
• Device Sequence Number: 1120955
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/27/2018

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: diff 2
• Device Catalogue Number: 6605500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 07/27/2018
• Patient Sequence Number: 1