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

Model Number TN DXH 520 CP HEMATOLOGY INSTRUMENT

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 309560669
• Report Number: 1061932-2023-00083
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590679781
• UDI-Public: (01)15099590679781(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/30/2023
• 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