MAUDE Adverse Event Report: BECKMAN COULTER SYNCHRON SYSTEMS AQUA CAL 1; CALIBRATOR, MULTI-ANALYTE MIXTURE

Model Number	LX AQUA CALIBRATOR LEVEL 1
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter applications specialist was sent to the customer site.A new lot of aquacal level 1 was used to resolve the issue.(b)(4).
Event or Problem Description
The customer reported erroneously low sodium (na) results on their unicel dxc 600 pro synchron system.The results were reported outside of the laboratory.The customer stated that quality control (qc) recovered within specifications prior to the event.There was no change to patient treatment in association with this event.

• Brand Name: SYNCHRON SYSTEMS AQUA CAL 1
• Common Device Name: CALIBRATOR, MULTI-ANALYTE MIXTURE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821 8000
• MDR Report Key: 7896408
• Report Number: 2050010-2018-01000
• Device Sequence Number: 1819241
• Product Code: JIX
• UDI-Device Identifier: 15099590233402
• UDI-Public: (01)15099590233402(17)190228(11)NO-DATA(10)72935498
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/20/2018

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: 02/28/2019
• Device Model Number: LX AQUA CALIBRATOR LEVEL 1
• Device Catalogue Number: 471288
• Device Lot Number: 72935498
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1