MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. UNICEL DXH 520 HEMATOLOGY INSTRUMENT; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 520 CP HEMATOLOGY INSTRUMENT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported one patient sample recovered with an incorrect sample identification number when run on their dxh520cp hematology instrument.No incorrect numerical results were reported outside the laboratory.There was no report of an injury or illness to the patient attributable to the output from the device in this event.No adverse event occurred.
Additional Manufacturer Narrative
The customer technical specialist (cts) verified what the customer reported via telephone.The cts explained if the tube barcode is not scanned or scanned correctly the system will apply the next sample id in the worklist.The cts also explained the correct way to run the samples by using the next icon and then barcoding the sample id on that screen, that way the system will apply the correct sample id.The issue was resolved by training the customer to correctly verify patient sample identification prior to running specimen on the instrument.Per dxh 520 cp ifu (pn:(b)(6)), ¿risk of misidentification.Verify specimen id in the worklist if the worklist contains entries.Confirm that the next specimen id is correct before the processing specimen message is displayed.¿ bec internal identifier: case-(b)(4).

• Brand Name: UNICEL DXH 520 HEMATOLOGY INSTRUMENT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• Manufacturer (Section G): BIT GROUP FRANCE; rue de la valsière; parc euromédicine ii,; montpellier cedex 34090 ; FR 34090
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 16326949
• Report Number: 1061932-2023-00083
• Device Sequence Number: 12723542
• Product Code: GKZ
• UDI-Device Identifier: 15099590679781
• UDI-Public: (01)15099590679781(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181475
• 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): 02/08/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TN DXH 520 CP HEMATOLOGY INSTRUMENT
• Device Catalogue Number: B40602
• 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: 01/30/2023
• Initial Report FDA Received Date: 02/08/2023
• 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
• Patient Sex: Unknown