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 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) could not determine the cause of the erroneous result.A broken y-fitting was replaced for an unrelated issue involving excessive vacuum chamber errors.The fse did not find any instrument malfunction related to the erroneous plt results the cause of the false high plt results is unknown.The beckman coulter internal identifier for this event is (b)(4).

Event Description

The customer reported that the unicel dxh 800 coulter cellular analysis system recovered incorrect platelet results on initial run for a sample.The sample was rerun in another instrument and a manual count was done to confirm that the results were erroneous.There were no instrument generated suspect flags associated with the results.Erroneous results were reported out of the lab and the doctor prematurely discharged the patient from the hospital with the result.The patient was readmitted when the results were amended and patient treatment was not affected.

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.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.Section h2 - additional information has been selected.Section h7 - recall, notification and modification have been selected.Section h9 - number has been updated to reflect the respective information for this event.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: 6750457
• MDR Text Key: 81305030
• Report Number: 1061932-2017-00010
• 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: 07/12/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 629029
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 07/30/2018
• Supplement Dates FDA Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2050012-0730/2018-011-C
• Patient Sequence Number: 1
• Patient Age: 20 MO