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 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) observed that the customer's two dxh520 (system id (b)(4) )have same device id (20) in the lis setup screen.The lis uses the instrument sequence number as the primary identifier to chart patient results into electronic record.There was one instance were both instruments had the same sequence number (same patient id) that resulted in a charting error.The customer was able to detect error and correct charting issue.The fse changed the device id on system id (b)(4) from id 20 to id 21 to correct duplicate device id issue.The fse also recommended to the lis vendor to change primary identifier from the sequence number to the patient id as best practice.Bec internal identifier (b)(4).

Event Description

The customer reported there was one instance were both their dxh520 cp hematology instruments had the same sequence number (duplicate patient id) that resulted in a charting error.Erroneous results were reported outside the laboratory, however, there was no reported change or effect on patient treatment.There was neither death or serious injury associated with the event.The customer detected and corrected the results of the charting issue.

• 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: 12611587
• MDR Text Key: 277233634
• Report Number: 1061932-2021-00120
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• 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: 09/16/2021
• 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