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

Model Number	TN,DXH 800 HEMATOLOGY SYSTEM
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the provided patient data confirms the reported event.The initial run showed lower wbc, rbc, hgb and higher plt compared to post transfusion run and initial sample rerun / redraw run two days later.The initial run had instrument generated r flag and platelet clumps system message alerting operator to further review results.The mcv correlated on all runs.Field service engineer (fse) checked the instrument and found no issues.The hgb lamp output was checked and found to be within specifications.The bsv (blood sample valve) and blood detectors were also found to be within specifications.The fse performed repeatability tests 4 times, each within specifications in regards to precision (cv¿s).Controls all recovered within specifications.On (b)(6) 2020 the customer indicated the patient complained of epigastric pain and due to the initial low hgb, the clinician thought the patient was bleeding.There was no information indicating the blood transfusion caused any additional change in patient treatment.It was confirmed the instrument recovered within control before and after this incident, all control results were acceptable.Additionally, the customer indicated ¿this (event) looked like a random error, perhaps caused by sample integrity¿.
Event or Problem Description
The customer reported a specific patient run on their unicel dxh 800 coulter cellular analysis system gave a low hemoglobin (hgb)=88 and white blood cell (wbc)=3.7 result.The patient was transfused with 1 unit (blood).A sample was run post transfusion the next day with higher than expected hgb at 152.The original sample was rerun two days after initial run with higher hgb results of 155 and 154 on both dxh instruments.There was no death or life-threatening injury associated with this incident.A patient was transfused with 1 unit of blood due to clinician¿s assessment of patient¿s reported complaint of epigastric pain and low hgb recovery.There was no information indicating the blood transfusion caused any additional change in patient treatment.

• 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: 9783200
• Report Number: 1061932-2020-00024
• Device Sequence Number: 19004713
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 03/03/2020

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 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 03/03/2020
• 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: 81 YR