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

Model Number TN,DXH 520 CP HEMATOLOGY INSTRUMENT

Device Problem Patient Data Problem (3197)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

The customer technical specialist (cts) assisted the customer via telephone.The customer does not like the worklist feature, wants to disable it because they are trying to scan the specimen tubes and incorrect specimen id is populating in the "next specimen id" area and is not matching the tube they want to run.Customer is concerned about wrong demographics being sent to lis.The customer wanted to run the sample manually and stated that they had scanned the barcode on the tube, but the scanned id did not make it onto the screen of dxh 520, instead on the screen was the test order which was on the top of the worklist, and that was what was transmitted over to the lis.The cts explained that the instrument will only match orders directly from the worklist which are automatically populated by the lis therefore the worklist must be used.The customer stated that after they followed the steps (per ifu) of hitting the next button on the screen, then scanning barcode and confirming, that they have not had any other problems with this issue.No instrument malfunction was identified.Bec internal identifier: case (b)(4).

Event Description

The customer reported one patient sample recovered with an incorrect specimen identification number and patient demographic compared to the tube they cycled on the dxh520 cp hematology instrument.There was no report of death, injury, or change to patient treatment as a result of this event.Erroneous results were sent to the lis system but the issue was caught before being reported out of the lab.

• Brand Name: UNICEL DXH 520 HEMATOLOGY INSTRUMENT
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER IRELAND; lismeehan; o'callaghan's mills; co. clare ; EI
• 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: 12363739
• MDR Text Key: 268054064
• Report Number: 1061932-2021-00106
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• 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: 07/28/2021
• 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