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 No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) could not identify a malfunction with instrument or the parts that would cause the reported issue.All voltages and pressures were within specification.The fse replaced the hgb lamp and sweep flow coil as a precaution for the reported issue.The diluent and waste filter were also replaced.The fse performed instrument calibration which passed and also performed instrument to instrument verification of parameters to confirm the instrument was running properly.With the information available, the reported event could not be confirmed.In an abundance of caution beckman coulter is submitting an mdr report for this event.Bec internal identifier - (b)(4).

Event Description

The customer reported erratic hemoglobin (hgb) and platelet (plt) results for patient samples on their ac*t diff 2 instrument.Results would not reproduce on patients.There were no results reported outside of the lab.Customer is not aware of any impact to patient treatment as a result of this event.Patient data has been requested but not provided.

• 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: 8426702
• MDR Text Key: 139052288
• Report Number: 1061932-2019-01359
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2019
• 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: 02/14/2019
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2005
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1