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

Model Number	AC*T DIFF 2
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient data was requested but not provided.The customer technical specialist (cts) advised the customer to rerun controls which voted out on both the wbc and rbc parameters.The cts guided the customer in running the clean baths bleach procedure two times, zapping the apertures two times and priming sweep flow three times resolving the reported issue.The customer then reran the patient samples on the same instrument post troubleshooting recovering correct results.Bec internal identifier - (b)(6).
Event or Problem Description
The customer reported recovering high plt results for patient samples run on the ac*t diff 2 instrument.Erroneous results were not reported out of the lab.There was no impact to patient treatment.

• Brand Name: COULTER ACT DIFF 2 ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 12503061
• Report Number: 1061932-2021-00116
• Device Sequence Number: 11759739
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)161202
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K990352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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: AC*T DIFF 2
• Device Catalogue Number: 6605500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1