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

Model Number TN,DXH 800 HEMATOLOGY SYSTEM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Unspecified Blood or Lymphatic problem (4434)

Event Date 06/23/2021

Event Type  Injury  

Manufacturer Narrative

The dxh800 instrument generated erroneous high mchc results on patient samples.The instrument also generated suspect hgb results but the hgb was confirmed to be correct by reruns on another instrument.The instrument was also failing mchc and hgb on controls.The field service engineer (fse) was at the customer site and confirmed the reported issue.The fse replaced valve vl167 to resolve the issue.Bec internal identifier - (b)(4).

Event Description

The customer reported the dxh800 instrument generated erroneous high mchc and erroneous hemoglobin(hgb) results on patient samples.Erroneous results were reported outside of the laboratory.On (b)(6) 2021, a bec applications specialist visited the site and was informed that patient care for 3 patients had been affected by the reported event.Two patients received unnecessary transfusions and one patient where hgb results were overestimated did not receive a needed transfusion.Per the customer there was no clinical impact that resulted from the two unnecessary transfusions or the one delayed transfusion.Per customer communication on 05-july-2021, the customer confirmed that a patient received an unnecessary transfusion based on erroneous low hgb results.

• Brand Name: ICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12278587
• MDR Text Key: 265153534
• Report Number: 1061932-2021-00094
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TN,DXH 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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