MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 600 HEMATOLOGY SYSTEM
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There were two patient samples results that were considered incorrect by the customer.The customer suspected the results because they did not match the patients' clinical history.One patient result had an instrument generated message alerting to possible iv contamination so it was immediately rerun and corrected.The second patient was not rerun until the following day and the results at that time were significantly lower for the hgb result resulting in the patient receiving a blood transfusion.As a result of the discordant result the transfusion was reportedly delayed one day.Information regarding the chronology of events and the impact to the patient have been requested but not provided by the customer.There is not enough information to identify the assignable cause or to confirm that the delay of treatment occurred as a direct result of an instrument malfunction.Bec internal identifier - case-(b)(4).
Event or Problem Description
The customer reported that their dxh 600 hematology instrument was generating erratic results for wbc, hemoglobin (hgb), and platelet (plt) values.The customer reported delay treatment for one patient in the form of a transfusion.Additional detail regarding the clinical impact to the patient was requested but not provided by the customer.

• Brand Name: UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: 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: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12849480
• Report Number: 1061932-2021-00161
• Device Sequence Number: 19921649
• Product Code: GKZ
• UDI-Device Identifier: 15099590192242
• UDI-Public: (01)15099590192242(11)171201
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

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 600 HEMATOLOGY SYSTEM
• Device Catalogue Number: B23858
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown