MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	TN, ACT5DIFF AL 100-240V
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	06/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2018 the field service engineer (fse) observed that the act5diff al instrument was found to have high platelet results.The fse cleaned the sample needle and rinse station, counting cell, counting line, reagent injector, counting syringe, and removed a large amount of crystals under the sample washing station to resolve the reported issue.Patient information was not provided by the customer.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported that their coulter act 5diff al hematology analyzer was generating erroneous high platelet (plt) results.There was no report of change or effect to patient treatment as a result of this event.Patient and control data was not provided by the customer.

• Brand Name: COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 7712626
• Report Number: 1061932-2018-01029
• Device Sequence Number: 2580305
• Product Code: GKZ
• UDI-Device Identifier: 15099590576479
• UDI-Public: (01)15099590576479(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2018

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: TN, ACT5DIFF AL 100-240V
• Device Catalogue Number: 175356
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/24/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2018
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1