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 Patient Data Problem (3197)

Patient Problem Lymphoma (3263)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

The bec customer technical specialist (cts) assisted with the customer's reported issue via telephone.The cts, through remote desktop sharing (rds), confirmed that the sample of tube id (b)(6) was analyzed on 17-jan-2024 at 5:57:29 p.M.: the rbc value was 4.665 and hgb value was 13.59, both results were considered erroneous.The erroneous results were released to the physician.Based on the information reported by the customer, there was an interval of 16 hours from the time the results were initially released to when the physician called the laboratory questioning the results.The patient sample was then rerun 18.75 hours after the initial run.The blood sample analyzed on 17-jan-2024, was analyzed on the instrument in manual mode.Based on the values of the erroneous results, the cts suspects poor agitation or non-agitation of the blood tube before running.Bec internal identifier - (b)(4).

Event Description

The customer called to report that an erroneous patient result for the hemoglobin (hb) and red blood cell (rbc) parameters was generated by the dxh800 hematology analyzer.The erroneous results were transmitted outside the laboratory causing the delay of patient treatment of 24 hours (delayed transfusion) for one patient.The initial result released to the physician was inconsistent with the patient's clinical state.The patient is in the palliative phase of waldenstrom lymphoma and was already hospitalized.The patient's transfusion and release was delayed an additional day.The patient did not suffer an adverse event as a result of the delayed transfusion.The transfusions are administered on a regular basis to the patient to relieve chronic anemia and not as emergency medical intervention.

• 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
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 18641928
• MDR Text Key: 334614875
• Report Number: 1061932-2024-00001
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization