MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT

Model Number	6L45-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Completed information: patient identifier: same patient: 6 days old: sid (b)(4) and 7 days old: sid (b)(4).Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated total bilirubin results generated on the architect c8000 processing module for one patient.The following data was provided: 6 days old: sid (b)(6) initial result = 245.2 umol/l, repeat with cobas roche = 180 umol/l new draw specimen: 7 days old: sid (b)(6) initial result = 274.4 umol/l, repeat with cobas roche = 224 umol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of historical data, and a review of labeling.Return testing was not completed as returns were not available.A review of the architect c803775 internal and external quality controls show they are ok.A review of tracking and trending did not identify any trends for the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.The bilirubin calibrator package insert helps with the standardization of the assay.The abbott bilirubin (both total and direct) assays are standardized to the doumas method which means we have a consistent standardization of our calibrators while other manufacturer's may use a different process or approach.Based on the investigation no systemic issue or deficiency of the total bilirubin for lot 55889uq09 was identified.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10298907
• Report Number: 3016438761-2020-00133
• Device Sequence Number: 11633993
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K060574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 02/28/2021
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 55889UQ09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C8000 PROCESSING MODULE; ARCHITECT C8000 PROCESSING MODULE; LIST 01G06-11, SERIAL (B)(6); LIST 01G06-11,SERIAL (B)(6)
• Patient Age: 6 DA