MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported erratic wbc, hgb, and rbc results on one patient sample when cycled on their dxh 900 hematology instrument.The customer questioned hgb results of 8.1 with r flag run at 10:37 am and 6.1 run at 11:21.Cts reviewed customer data and determined that the sample run at 11:21 am had suspect mixing and advised the customer to confirm results with a redraw of the patient.Patient hgb result after the redraw was 7.9.The customer called back the same day to state that a released erroneous result caused the patient to be administered a transfusion.The instrument generated r flags for the result in question and was held by the instrument but was manually released by the laboratory.There was no death associated with this event.
Additional Manufacturer Narrative
The customer technical support (cts) confirmed that the patient was transfused unnecessarily after release of the sample run on (b)(6) 2023 at 6:36 am.There was no report that the patient suffered any adverse effect from having been administered the transfusion.The instrument generated r flags and system/suspect messages for the operator released results.Due to laboratory error, the patient results were released without further testing or review.The cts determined the questioned sample from (b)(6) 2023 11:21:40 had suspect mixing and advised the customer to redraw and rerun patient sample.There was no malfunction identified.The event occurred as a result of user error.Per unicel dxh 900 series with system manager software instructions for use, part c06947ac: page 6-24; table 6.1.Flag-description r flag: review the result.System messages: all system messages are accompanied by r (review) flags.Exceptions are the system messages associated with an aspiration error (p flag) and the non-blood specimen message (n flag).A system message indicates an event occurrence that may affect the operation of the system or the quality of the results or requires operator intervention.The occurrence of any system message is shown in the history log.Bec internal identifier: (b)(4).

• Brand Name: UNICEL DXH 900 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 COUTER; 11800 sw 147th ave.; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 16905809
• Report Number: 1061932-2023-00094
• Device Sequence Number: 17482665
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)220321
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/10/2023

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 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: C11478
• 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: 04/21/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown