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

Model Number LX AQUA CALIBRATOR LEVEL 1

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  malfunction  

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 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
• Type of Device: CALIBRATOR, MULTI-ANALYTE MIXTURE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER; 2470 faraday ave; carlsbad CA 92010
• Manufacturer Contact: david davis ; 250 s. kraemer blvd; brea, CA 92821-8000
• MDR Report Key: 7896408
• MDR Text Key: 122168307
• Report Number: 2050010-2018-01000
• Device Sequence Number: 1
• Product Code: JIX
• UDI-Device Identifier: 15099590233402
• UDI-Public: (01)15099590233402(17)190228(11)NO-DATA(10)72935498
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071277
• 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
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/20/2018
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1