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 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide any data to and an instrument malfunction could not be determined.The customer continued to run the instrument without any further issues.The beckman coulter (b)(4).

Event Description

The customer reported that the unicel dxh 800 coulter cellular analysis system showed sample demographics from a patient run in 2015 on a patient run on (b)(6) 2016.The samples were rerun on another instrument which gave the same result.The customer did not provide a copy of the erroneous patient results or the system data.Erroneous results were not reported out of the lab.There was no change in patient treatment in connection with this event.

Manufacturer Narrative

Correction to additional mfr narrative; the attached file is not applicable to this event.The attached file has been removed.

• 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
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami 33196
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th ave; 32-s08; miami 33196 ; 3053802031
• MDR Report Key: 6682979
• MDR Text Key: 78910917
• Report Number: 1061932-2017-00007
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• 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: B24802
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1