MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 800 HEMATOLOGY SYSTEM
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was at the customer site and confirmed the reported issue.The fse inspected the instrument and found that the rbc aperture #2 was plugged.A brush was used to clear out the obstruction in the aperture and resolve the issue.Bec internal identifier (b)(4).
Event or Problem Description
The customer reported that a specific patient sample run on their dxh800 instrument gave a high platelet (plt) result compared to rerun of the same specimen and a slide review.The customer technical specialist (cts) documented that the initial sample was run on (b)(6) 2020 at 19:42, with a non-credible plt result (1098).The customer reran the same specimen at 23:21, with a plt result of 260, a slide review was also performed to confirmed the second run (plt=260).Instrument printouts were requested but not provided for this event, instrument flagging, if present could not be determined.There was no report of death or injury associated with this incident.There was no impact or change to patient treatment.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 9709332
• Report Number: 1061932-2020-00015
• Device Sequence Number: 16743212
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• 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): 02/13/2020

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 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1