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 Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier = sid= (b)(6).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 on architect c16000 processing module for one pediatric patient.The results provided were: on (b)(6) 2020, sid: (b)(6); initial total bilirubin=22.29 mg/dl/ repeated on alinity=21 mg/dl and 20 mg/dl/ repeated on roche instrument=15.5 mg/dl there was no reported impact to patient management.
Additional Manufacturer Narrative
A ticket search was performed for the architect total bilirubin, reagent lot number 56776uq02.An investigation was performed for the customer issue and included a review of the complaint text, a search for tracking and trending, a review of historical performance and product labeling.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the total bilirubin assay, lot number 56776uq02 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: 10678182
• Report Number: 3016438761-2020-00247
• Device Sequence Number: 2757636
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 11/09/2020

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: 56776UQ02
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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: ARC C16K PRC MOD, 03L77-01, C1601165.; ARC C16K PRC MOD, 03L77-01, C1601165.