MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT DIFF 2 HEMATOLOGY INSTRUMENT; 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	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) inspected the instrument and could not identify an instrument malfunction.All qc results were within range, there were no flags for iqap, and no startup fails for plt.With the information available the assignable cause for the questionable results could not be confirmed.The customer did not call back to report any issues.Bec internal identifier: (b)(4).
Event or Problem Description
The customer reported their act diff 2 hematology instrument questionable generated high platelet (plt) results on patient samples.The results in question were reported outside the laboratory.There was no reported change or effect on patient treatment.There was neither death nor serious injury associated with the event.

• Brand Name: COULTER ACT DIFF 2 HEMATOLOGY INSTRUMENT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 15908898
• Report Number: 1061932-2022-00073
• Device Sequence Number: 5914482
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown