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	Output Problem (3005)
Health Effect - Clinical Codes	Misdiagnosis (2159); Test Result (2695)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information available does suggest there was a serious injury in the form of an bone marrow draw that was not required by one patient.The information available does suggest there was a malfunction.Additional information has been requested for this event and the investigation is still ongoing.This report has been submitted for the unrequired bone marrow draw, an update will be provided as new information becomes available.Internal bec identifier.(b)(4).
Event or Problem Description
The customer reported that their unicel dxh 800 coulter cellular analysis system had generated wbc carryover and variable lymph messages while running s sample.This prompted a manual slide assessment for the patient and as a result of the slide, the patient was thought to have relapsed and a bone marrow drawing was done.The sample was for a (b)(6) year old female patient with acute myeloid leukemia (aml).The slide review prompted the bone marrow procedure.It was confirmed that the patient had not relapsed as initially suspected.The patient recovered from the procedure without complication.
Additional Manufacturer Narrative
Result and conclusion codes have been updated to reflect current information.The field service engineer (fse) inspected the dxh800 instrument and found no malfunctions of the instrument.Upon further discussion on (b)(6) 2019 with the laboratory doctor, the incident did not occur as a result of the unicel dxh 800 coulter cellular analysis system as originally reported, the discrepancy occurred as a result of carryover on the slide produced by the unicel dxh slidemaker stainer coulter cellular analysis system (reported in mdr# 1061932-2019-01787).It was confirmed that the results generated on the dxh800 were consistent and considered correct.Bec internal identifier - (b)(4).Related events - (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: 8782923
• Report Number: 1061932-2019-01708
• Device Sequence Number: 11429495
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)161209
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• 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,Followup
• Report Date (Section B): 08/23/2019

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
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR