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 09/22/2021

Event Type  malfunction  

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 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
• 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: 12611580
• MDR Text Key: 277149210
• Report Number: 1061932-2021-00121
• 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: 09/22/2021
• 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