MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Service was not scheduled for this event.The instrument flagged the results as intended, the information available does not suggest that the instrument malfunctioned.Beckman coulter is reporting this event for the delay of transfusion that resulted from the flagged erroneous result.Bec internal identifier case (b)(4).
Event or Problem Description
The customer reported that their dxh 800 hematology instrument generated erratic erroneous platelet (plt) counts for a patient undergoing chemotherapy.A delay in patient treatment occurred as a result of this event.The customer indicated that there were no adverse events associated with this event and the impact to treatment was the delay of a transfusion.The physician knew the patient and the results were inconsistent with the patient's clinical history.The results were then submitted for manual count and verified on a non-beckman coulter instrument.Printouts provided as evidentiary support for this event, indicate that the instrument flagged the sample results, triggering suspect messages (giant platelets), system messages (platelets aggregates, rbc-plt overlap), and r-flags for the specimens.The flags notify the operator to review the results according to their laboratory¿s policy for reviewing the patient sample results.
Additional Manufacturer Narrative
Beckman coulter had originally reported this event for the delay of transfusion that resulted from the flagged erroneous result.Upon further assessment of the patient results deemed correct by the customer, the cancellation of the transfusion was reasonable.The results would not warrant the implementation of their platelet transfusion protocol, where plt equal or less than 9.9 (9900/l) triggers a transfusion.The customer provided the following clarification: as per their protocol plt = 9.9 (9900/l) will warrant a transfusion.Manual count was plt = 80 (80 000/l).Xn sysmex (fluorescence) with plt = 60 (60 000 /l).This assessment was confirmed by the chief medical officer at beckman coulter.Bec internal identifier - (b)(4).

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 8300416
• Report Number: 1061932-2019-01237
• Device Sequence Number: 13865466
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)180309
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: B24802
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/04/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 02/02/2019
• Supplement Report FDA Received Date: 05/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR