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 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) could not determine the cause of the erroneous result.The fse did not find any instrument malfunction related to the erroneous plt results.The raw data analysis did not provide any information regarding the cause of the issue.The cause of the false high plt results is unknown.The beckman coulter internal identifier for this event is (b)(6).

Event Description

The customer reported that the unicel dxh 800 coulter cellular analysis system recovered incorrect platelet results on a run for one patient sample.The customer suspected this result was incorrect because the same patient was analyzed previously on (b)(6) 2017 and the plt result was lower.There were no instrument generated suspect flags associated with the results.The customer reran the sample on another instrument and it gave a higher result which was considered correct.Erroneous results were not reported outside of the laboratory.There was no change or effect to patient treatment related to 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 (b)(6) 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 (b)(6) 2018.The field action ncludes 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 sectionh9 - 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: 6815033
• MDR Text Key: 83678771
• Report Number: 1061932-2017-00011
• 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: foreign,health professional,u
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• 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
• 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