MAUDE Adverse Event Report: ABBOTT LABORATORIES TOTAL BILIRUBIN; DIAZO COLORIMETRY, BILIRUBIN

Model Number	6L45-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for architect total bilirubin reagent ln 6l45-21/lot number 56889uq02.Return testing was not completed as returns were not available.The tracking and trending review determined no trends were identified for discrepant patient results for the product.Worldwide data was reviewed and determined that the patient median result for total bilirubin reagent lot number 56889uq02 is within established control limits.Retesting of the samples gave expected normal results.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue was adequately addressed.Based on the investigation, no systemic issue or deficiency of the architect total bilirubin reagent lot number 56889uq02 was identified.
Event or Problem Description
The customer reported false decreased total bilirubin results for 2 patient samples while running on the architect c8000 processing module.The following data was provided on (b)(6) 2020 (reference range: 0.2-1.2 mg/dl): sample 1 = initial = 0.13 mg/dl; repeat result = 0.74 mg/dl.Sample 2 = initial = <0.10 mg/dl; repeat result = 0.94 mg/dl there was no impact to patient management reported.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 10838627
• Report Number: 3016438761-2020-00299
• Device Sequence Number: 11823647
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121985
• 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
• Report Date (Section B): 11/13/2020

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: 07/31/2021
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 56889UQ02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1