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

Model Number AC*T DIFF 2

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

The bec field service engineer (fse) went to the customer site and confirmed what the customer had reported.The customer had shutdown and powered off the instrument with cleaner over night.The fse cleaned the instrument, checked the incoming fluidics lines and emptied out fluid from the vacuum trap to resolve the issue.While there he mixed a new box of reagents and adjusted the hemoglobin gains slightly.Bec internal identifier: (b)(4).

Event Description

The customer reported that their act diff 2 hemaotlogy instrument generated erroneous high platelet (plt) and red blood cell (rbc) results on four patient samples and controls.The customer reported that controls were recovering high for rbc and plt.Four patient results that were considered erroneous were provided by the customer, there were no instrument generated flags or system messages generated.Erroneous results were not reported outside of the lab.The was no report of a serious injury or change to patient treatment as a result fo this event.

• 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: angela vettel ; 250 s kraemer blvd,; brea, CA 92821 ; 7149613625
• MDR Report Key: 15741440
• MDR Text Key: 307280894
• Report Number: 1061932-2022-00068
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2022
• 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
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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