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

Model Number	TOTAL BILIRUBIN
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer used a new cartridge of the same lot of total bilirubin (tbil) reagent to resolve the issue.
Event or Problem Description
The customer reported obtaining erroneously low patient results for total bilirubin (tbil) involving the au680 clinical chemistry analyzer.The low results were not reported outside the laboratory.Quality control was within the laboratory's established ranges prior to the generation of the low results.There was no change to patient treatment in association with this event.
Additional Manufacturer Narrative
Upon further investigation, the customer continued to run patient samples after the calibration failed.This is considered a use error.

• Brand Name: TOTAL BILIRUBIN AU REAGENT
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• MDR Report Key: 7491944
• Report Number: 9680746-2018-00002
• Device Sequence Number: 10803155
• Product Code: CIG
• UDI-Device Identifier: 15099590010119
• UDI-Public: (01)15099590010119(17)180901(11)170901(10)2529
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K924964
• 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,Followup
• Report Date (Section B): 04/11/2018

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: No Information
• Device Expiration Date: 09/01/2018
• Device Model Number: TOTAL BILIRUBIN
• Device Catalogue Number: OSR6112
• Device Lot Number: 2529
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1