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

Model Number	AC*T-DIFF F/ASSY,FINAL TEST LEVEL, 16 PARAMETERS
Medical Device Problem Code	Priming Problem (4040)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was at the customer site and confirmed the reported issue.The fse cleaned the sample syringe assembly and the probe wipe block assembly.The fse flushed the probe vacuum pathway and tightened the diluent filter connections to resolve the issue.
Event or Problem Description
The customer reported that the results generated on their act diff hematology instrument for two patient samples were erroneously high.Erroneous results were reported out of the laboratory.One of the patients were initially sent to the hospital emergency room but the recommendation was reversed once the customer identified an instrument problem.No other impact to patient or treatment was reported.Additional information about the impacted patient was requested.The customer technical specialist (cts) attempted to get the details regarding the patient who went to er but was unable to get additional information from the customer.

• Brand Name: COULTER ACT DIFF ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 12140601
• Report Number: 1061932-2021-00083
• Device Sequence Number: 3820872
• Product Code: GKZ
• UDI-Device Identifier: 15099590264734
• UDI-Public: (01)15099590264734(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K973634
• 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): 07/08/2021

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 F/ASSY,FINAL TEST LEVEL, 16 PARAMETERS
• Device Catalogue Number: 6706366
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1