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	12/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was at the customer site and confirmed what the customer reported.To resolve the issue the fse replaced the rbc chamber and rbc latex calibrator.Bec internal identifier (b)(4).
Event or Problem Description
The field service engineer (fse) was at the customer site and confirmed what the customer had reported.To resolve the issue the fse replaced the rbc chamber and the rbc latex calibrator.Bec internal identifier (b)(4).
Additional Manufacturer Narrative
Follow up 01: section b5 describe event or problem: entry corrected to reflect required information.Section h10 additional manufacturing narrative: new information regarding the chronology of events regarding the resolution was received.The customer initially cleaned the instrument, and the issue was thought to be resolved.The customer called back on (b)(6) 2022 stating the issue was happening again.The field service engineer (fse) was at the customer site and confirmed what the customer had reported.To resolve the issue the fse replaced the rbc chamber and rbc latex calibrator.The fse confirmed that there were no leaks in the instrument and controls all passed.Bec internal identifier (b)(4).
Event or Problem Description
The customer reported erroneous high platelet (plt) results were generated on their dxh 520 cp hematology instrument.There was no report of an adverse event as a result of this occurrence.There was no report of death, injury, or change to patient treatment.

• 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
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 13233696
• Report Number: 1061932-2022-00006
• Device Sequence Number: 4547173
• Product Code: GKZ
• UDI-Device Identifier: 15099590679781
• UDI-Public: (01)15099590679781(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown