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

Model Number	B24802
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) evaluated the instrument and did not find an instrument malfunction.The cause of the false high plt results is unknown.The bec internal identifier for this event is case-(b)(4).
Event or Problem Description
The customer reported false high platelet (plt) results were generated on a unicel dxh 800 coulter cellular analysis system.There were no flags or system messages reported by the customer.The customer reran the sample on a competitive analyzer, which generated lower results.The competitive analyzer results correlated with the plt count from a manual slide review.There was no effect or change to patient treatment associated with the reported event.
Additional 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 (b)(6) 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 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 - case(b)(4).

• 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: 7688466
• Report Number: 1061932-2018-01026
• Device Sequence Number: 16472827
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment,Notification,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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: B24802
• Device Catalogue Number: B24802
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/16/2018
• Initial Date Received by Manufacturer: 06/16/2018
• Supplement Date Received by Manufacturer: 10/14/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/15/2018
• 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