MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) CLINICAL CHEMISTRY 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no further patient information was 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 depressed total bilirubin on architect c8000 processing module for multiple patients.One example patient result provided: sid (b)(4) total bilirubin result=0.20 mg/dl/ repeated=0.20 mg/dl/ repeated=0.50 mg/dl (normal reference range=0.2 to 1.2 mg/dl).The percent bias between the two results are 60%.There was no reported impact to patient management.
Additional Manufacturer Narrative
A ticket search was performed for the architect total bilirubin, reagent lot number 55179uq05.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.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 55179uq05 was identified.

• Brand Name: CLINICAL CHEMISTRY 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: 10309688
• Report Number: 3016438761-2020-00136
• Device Sequence Number: 3417000
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/15/2020

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: 10/31/2020
• Device Model Number: 6L45-41
• Device Catalogue Number: 06L45-41
• Device Lot Number: 55179UQ05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/15/2020
• 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: ARCHITECT C8000 SYSTEM; ARCHITECT C8000 SYSTEM; LIST # 01G06-56, SERIAL # (B)(4).; LIST # 01G06-56, SERIAL # (B)(4).