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

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	04/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information: no further information was provided.
Event or Problem Description
The customer obtained falsely depressed architect total bilirubin results.The customer uses an adult normal range of 0.2 to 1.2 mg/dl.Sample id (b)(6) for a (b)(6) year old female: (b)(6) 2020 1.12 mg/dl; patient's previous result (b)(6) 2018 1.50 mg/dl.No impact to patient managmement was reported.
Additional Manufacturer Narrative
Review of complaint activity associated with reagent lot 54565uq02 did not identify an increase in complaint activity.However, an increase in complaint activity was identified associated with calibrator lot 52584fd01, which was in use at the customer site.Trending reports associated with the architect total bilirubin reagent and calibrator did not identify any trends.Return testing was not completed as returns were not available.Due to the increase in complaint activity the calibrator lot was further evaluated across two alternate reagent lots.All results were within the expected ranges indicating acceptable product performance.Manufacturing documentation was reviewed and did not identify any issues associated with the issue.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect total bilirubin assay 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: 10063961
• Report Number: 3016438761-2020-00067
• Device Sequence Number: 2625500
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/10/2020

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: 07/31/2020
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 54565UQ02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 05/16/2020
• Supplement Report FDA Received Date: 07/10/2020
• 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, LIST 01G06-11,; ARCHITECT C8000, LIST 01G06-11,; SERIAL (B)(4); SERIAL (B)(4)
• Patient Age: 24 YR