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

Model Number N/A

Device Problem Output Problem (3005)

Patient Problem Not Applicable (3189)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument.The fse did not find a specific malfunction.The fse replaced the vacuum isolator chamber, waste filter, red blood cell (rbc) bath filters, aspiration sample probe and dilution mixing check valves as a preventative measure.The fse verified that the instrument was not generating erroneous results.(b)(4).

Event Description

The customer reported the couter act diff 2 instrument erroneous wbc (white blood cell) and plt (platelet) results for one patient.The initial sample run on the instrument generated a higher wbc and plt count than the rerun on the reference lab instrument.The plt count was very elevated on the act diff 2.There was no instrument flagging generated on these parameters.Erroneous results were reported outside of the laboratory but there was no change in patient treatment.

Manufacturer Narrative

(b)(6).

• Brand Name: COULTER AC T DIFF 2 ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-s08; miami 33196 ; 3053802031
• MDR Report Key: 6195740
• MDR Text Key: 63066859
• Report Number: 1061932-2016-00987
• Device Sequence Number: 1
• Product Code: GKZ
• 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,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6605500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1