MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided by the customer.The field service engineer (fse) was at the customer site and confirmed what the customer reported.Upon inspection of the instrument the fse observed a blood sampling valve (bsv) drive failure.To resolve the issue the fse replaces the bsv and rbc bath and bracket.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported that their dxh 900 hematology instrument generated erroneous high platelet (plt) results on patient samples.There was no indication of erroneous results being reported outside the laboratory.There was no report of change or effect on patient treatment.

• Brand Name: UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12755556
• Report Number: 1061932-2021-00129
• Device Sequence Number: 19616379
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)210322
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2021

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 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: C11478
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2021
• Initial Report FDA Received Date: 11/06/2021
• 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