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

Device Problem Output Problem (3005)

Patient Problems Misdiagnosis (2159); Test Result (2695)

Event Date 06/12/2019

Event Type  Injury  

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 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.

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
• Type of Device: 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: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 8782923
• MDR Text Key: 150818351
• Report Number: 1061932-2019-01708
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)161209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: B24802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR