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

Model Number	TN,DXH 520 CP HEMATOLOGY INSTRUMENT
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER IRELAND; lismeehan; o'callaghan's mills; co. clare ; EI
• MDR Report Key: 12611587
• Report Number: 1061932-2021-00120
• Device Sequence Number: 1337003
• Product Code: GKZ
• UDI-Device Identifier: 15099590679781
• UDI-Public: (01)15099590679781(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1