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	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 reported falsely depressed architect total bilirubin results on one patient.The results provided were: sid (b)(6) initial result bilirubin, total = >25.00 mg/dl, repeated bilirubin, total = 1.30 mg/dl, repeated on the alinity bilirubin, total = 23.17 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) reviewed assay parameters and adjusted the wavelengths for each assay per the package insert.Total and direct bilirubin assays were then calibrated and both levels of controls were in range.Retesting of the samples gave expected results.A review of tickets determined that there is normal complaint activity for architect total bilirubin reagent ln 6l45-21/lot number 56466uq12.Review of tracking and trending reports did not identify any related trends for discrepant patient results for the product.World wide data was reviewed and determined that the patient median result for total bilirubin reagent lot number 56466uq12 is within established control limits, therefore, no unusual reagent lot performance was identified.Return testing was not completed as returns were not available.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 is sufficiently addressed.Based on the investigation, the architect total bilirubin reagent lot number 56466uq12 is performing as intended, no systemic issue or deficiency 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: 10924503
• Report Number: 3016438761-2020-00317
• Device Sequence Number: 19050295
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 12/14/2020

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: 05/31/2021
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 56466UQ12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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 C4 PROC MOD, 02P24-01, C462115; ARC C4 PROC MOD, 02P24-01, C462115