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

Model Number	6L45-41
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no further patient information provided by the customer.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 decreased total bilirubin results generated on the architect c16000 processing module for multiple patient comparison samples and a shift in quality control results.The sids ranging from (b)(6) generated a bias ranging between 2.9% to 21.4% between two different calibrator lot numbers.It is unknown if the results are being used for individual patient management.No impact to patient management.
Event or Problem Description
During a patient comparison study the customer observed falsely depressed total bilirubin results generated on the architect c16000 processing module for several samples upon use of calibrator lot 05647fd01.The biases observed with this calibrator lot ranged from 2.9% to 22.5%.The customer also reported an observed negative shift in qc results during this time.There was no impact to patient management reported.
Additional Manufacturer Narrative
Corrections to the event description of the initial report have been submitted.
Additional Manufacturer Narrative
Return testing was not completed as returns were not available.A review of tickets was performed 55749uq08 and there were no trends identified related to patient results.Accuracy testing was performed with a retained kit of lot 55749uq08, quality controls, and a patient serum pool all quality control values were within specifications, and the patient serum pool generated the same mean results across multiple in-house systems.A review of manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation no product deficiency was identified for the total bilirubin assay, lot 55749uq08.

• 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: 9707745
• Report Number: 1628664-2020-00056
• Device Sequence Number: 19668527
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 05/26/2020

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: 01/31/2021
• Device Model Number: 6L45-41
• Device Catalogue Number: 06L45-41
• Device Lot Number: 55749UQ08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 03/29/2020; 05/20/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 04/09/2020; 05/26/2020
• 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 C16000 PROCESSING MODULE; ARCHITECT C16000 SYSTEM; ARCHITECT C16000 SYSTEM; LN 03L77-01 SERIAL (B)(6); LN 03L77-01, SERIAL (B)(6); LN 03L77-01, SERIAL (B)(6)