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

Model Number	6L45-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information included.No additional information was provided.An evaluation is in process.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated total bilirubin results were generated for a patient on the architect c4000 analyzer.The customer stated that sid (b)(6) generated a result of 372.6 umol/l.An hour later, the customer stated a new sample was obtained from the patient sid (b)(6) which generated a result of 232.5 umol/l (shift of 60.26%).There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for total bilirubin reagent, lot 58354uq08.A review of trending determined no trends for falsely elevated results for the total bilirubin reagent were identified.Return testing was not completed as returns were not available.The original sample was hemolyzed and a new sample was tested with lower normal result and qc was within expected ranges during the initial sample testing, indicating the assay is performing as expected.Manufacturing documentation was reviewed and no issues were found.A review of the product labeling concluded that the customer issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the total bilirubin reagent ln 6l45-21 lot number 58354uq08 was identified.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 11974710
• Report Number: 3016438761-2021-00215
• Device Sequence Number: 3404368
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/06/2021

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: 01/31/2022
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 58354UQ08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 08/06/2021
• 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: ARC C4 PROC MOD, 02P24-01, C461193; ARC C4 PROC MOD, 02P24-01, C461193; ARC C4 PROC MOD, 02P24-01, (B)(4)