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

Model Number TN, ACT5DIFF AL 100-240V

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 06/24/2018

Event Type  malfunction  

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 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
• 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: 7712626
• MDR Text Key: 114804493
• Report Number: 1061932-2018-01029
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590576479
• UDI-Public: (01)15099590576479(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TN, ACT5DIFF AL 100-240V
• Device Catalogue Number: 175356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/24/2018
• Date Manufacturer Received: 06/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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