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	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer technical support (cts) specialist discussed the maintenance of the instrument and the customer said that the instrument was due for monthly bleaching.The customer was advised to bleach and clean the wbc filter and to call back if the issue was not resolved.The customer agreed to do so and has not called back.Bec internal identifier case-(b)(4).
Event or Problem Description
The customer reported that their dxh520 cp hematology instrument had generated erroneous high platelet (plt) results on patient samples.Erroneous results were not reported outside of the laboratory.There was no report of serious injury or impact to patient treatment related to this event.Printouts were requested multiple times but not provided by the customer.

• 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: 12611580
• Report Number: 1061932-2021-00121
• Device Sequence Number: 1337002
• Product Code: GKZ
• UDI-Device Identifier: 15099590679781
• UDI-Public: (01)15099590679781(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 09/22/2021
• 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