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

Model Number	TN,DXH 800 HEMATOLOGY SYSTEM
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Unspecified Blood or Lymphatic problem (4434)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer; brea CA 92821
• MDR Report Key: 12278587
• Report Number: 1061932-2021-00094
• Device Sequence Number: 3761245
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 07/05/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1