MAUDE Adverse Event Report: BECKMAN COULTER LX AQUA CALIBRATOR LEVEL 1

Catalog Number	471288
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer replaced aqua calibrator level 1 l/n 72853811 with l/n 72935498 to resolve the issue.
Event or Problem Description
The customer stated erroneously low na (sodium) patient results were generated on their unicel dxc 600 pro synchron system using aqua calibrator level lot 72853811.The customer stated the patient sample results were reported outside of the laboratory, however the results were amended/corrected with no change to patient treatment.A review of the customer provided data confirms the instrument generated 1 (one) erroneously low na patient result.A review of the na quality control (qc) data provided shows recoveries for level 2 were greater than 2sd low of the instrument control mean on the event date.

• Brand Name: LX AQUA CALIBRATOR LEVEL 1
• Common Device Name: LX AQUA CALIBRATOR LEVEL 1
• Manufacturer (Section D): BECKMAN COULTER; 2470 faraday ave; carlsbad CA 92010
• MDR Report Key: 7222202
• Report Number: 2050010-2018-00001
• Device Sequence Number: 2006429
• Product Code: JIX
• UDI-Device Identifier: 15099590233402
• UDI-Public: (01)15099590233402(17)181130(11)NO-DATA(10)72853811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2018

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 Expiration Date: 11/20/2018
• Device Catalogue Number: 471288
• Device Lot Number: 72853811
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1