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

Model Number	629029
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 31-jul-2018, the field service engineer (fse) was at the customer site and found that the wbc aperture was clogged.The wbc apertures and valves vl106 and vl105 were cleared and the rbc bath was also replaced.The fse confirmed that the reported event was no longer occurring.Daily checks, qc and latron were run successfully and the system validated to meet published performance specification.The assignable cause of the event was clogged apertures at the wbc bath.An improvement for plt flagging was developed and released as a part of a software update to the dxh800 that is designated v3.2.1 on 22-dec-2017; approximately 11.5% of the worldwide product installed base has been upgraded as of 13-jul-2018.Due to an increase in the number of complaints received related to unflagged erroneously high plt patient results released from the lab, bec has determined that a field action is warranted.Field action (fa-33718) was approved on 30-jul-2018.The field action includes a software patch for the improvement for the plt flagging component of v3.2.1, which will expedite installation of this improvement for rest of the installed base.The recall (fa-33718) includes notification to the customer and correction of the issue via software update.(b)(4).
Event or Problem Description
The customer reported that their 510k unicel dxh 800 coulter cellular analysis system generated vote outs on wbc/differentials and platelets (plt).Daily checks had failed, then passed after further troubleshooting.Patient samples were rerun to verify instrument operation following troubleshooting.Plt results were not matching earlier plt results on two (2) patients.Results from two patients ((b)(6)) were provided.Initial run on each sample showed lower plt result compared to the same sample rerun several hours later following troubleshooting.No flags present for either run.However, further review showed each sample displayed individual aperture vote out on the rerun possibly indicating restricted aperture flow.Manual slide estimate for patient (b)(6)correlated with the initial, lower plt result.Manual plt estimate was not provided for patient (b)(6).No erroneous results were reported outside the laboratory.There was no injury, no exposure and no harm to patient or user associated with the reported event.

• 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: 7815408
• Report Number: 1061932-2018-01038
• Device Sequence Number: 1434139
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Repair,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 08/24/2018

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: 629029
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/27/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/24/2018
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2050012-0730/2018-011-C
• Patient Sequence Number: 1
• Patient Age: 64 YR