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

Model Number N/A

Device Problem Output Problem (3005)

Patient Problem Not Applicable (3189)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument.The fse did not find any instrument malfunction.The fse confirmed that the instrument was running per specifications.(b)(4).

Event Description

The customer reported the unicel dxh 800 coulter cellular analysis system generated erroneous high un-flagged platelet (plt) results for one patient compared to a manual slide estimate.There was no report of injury or biohazard exposure to open wounds or mucous membranes.Erroneous results were reported out of the lab.There was no change in patient treatment in connection with this event.

Manufacturer Narrative

Follow up 01: 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.The field action will include 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.Additional information: the recall (fa-33718) includes notification to the customer and correction of the issue via software update.Bec internal identifier: (b)(4).

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• MDR Report Key: 6099549
• MDR Text Key: 59866152
• Report Number: 1061932-2016-00958
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 629029
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2050012-0730/2018-011-C
• Patient Sequence Number: 1
• Patient Age: 3 YR