MAUDE Adverse Event Report: BECKMAN COULTER TOTAL BILIRUBIN REAGENT; DIAZO COLORIMETRY, BILIRUBIN

Model Number	CX/LX TBIL KIT 2 X 400 TEST
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched and evaluated the device.The field service engineer (fse) used a new cartridge of the same lot of total bilirubin (tbil) reagent to resolve the issue.(b)(4).
Event or Problem Description
The customer reported receiving erroneous low patient results for total bilirubin (tbil) on the unicel dxc 660i synchron access clinical system.The erroneous results were reported outside of the lab.There was no change in patient treatment in association with this event.

• Brand Name: TOTAL BILIRUBIN REAGENT
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821 8000
• MDR Report Key: 8182708
• Report Number: 2050010-2018-01001
• Device Sequence Number: 13818037
• Product Code: CIG
• UDI-Device Identifier: 15099590625597
• UDI-Public: (01)15099590625597(17)200831(11)NO-DATA(10)M808018
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: D127970
• 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): 12/19/2018

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: 08/31/2020
• Device Model Number: CX/LX TBIL KIT 2 X 400 TEST
• Device Catalogue Number: 476861
• Device Lot Number: M808018
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1