MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	TN ACT5DIFF AL 100-240V
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	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.The field service engineer (fse) observed that the platelet (plt) background and control samples were very high after the customer installed previously used diluent reagent, causing the reported event.The fse instructed the customer to install new diluent reagent resolving the issue.Bec internal identifier (b)(4).
Event or Problem Description
The field service engineer (fse) reported platelet (plt) background and control samples were very high on the customer¿s act 5diff al analyzer after customer installed used diluent reagent.There was no report of an adverse event.There was no report of erroneous patient results reported outside the laboratory.There was no impact to patient treatment.The fse provided one example showing the reported elevated plt result issue on a patient sample and the instrument had failed startup for plt.

• Brand Name: COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
• 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 avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 14247004
• Report Number: 1061932-2022-00026
• Device Sequence Number: 17218992
• Product Code: GKZ
• UDI-Device Identifier: 15099590576479
• UDI-Public: (01)15099590576479(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K032013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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: TN ACT5DIFF AL 100-240V
• Device Catalogue Number: 175356
• 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: 04/07/2022
• Initial Report FDA Received Date: 04/28/2022
• 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