MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT

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	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier = (b)(6).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 elevated total bilirubin on architect c16000 analyzer for multiple patient samples.The results were provided: on (b)(6) initial =82.92/repeat=12.02(customer reference range=3.4-20.5 umol/l), sid (b)(6) initial=348.72/repeat=16.20, sid (b)(6) initial=98.83/repeat=7.87, sid (b)(6) initial=94.52/repeat=8.06, sid (b)(6) initial=85.99/repeat=6.89, sid (b)(6) initial=225.53/repeat=24.46, sid (b)(6) initial =169.75/repeat=6.00, sid (b)(6) initial= 78.45/repeat=11.84, sid (b)(6) initial=248.26/repeat=14.65.There was no reported impact to patient management.
Additional Manufacturer Narrative
The evaluation of complaint data for the likely cause architect total bilirubin assay lot 55889uq09 found no other similar complaints.The evaluation of the list number (6l45) for complaint activity found there are no trends for the product related to patient results.No customer returns were available for evaluation.A review of the manufacturing documentation did not identify any issues associated with the customers observation.A review of the product labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9752771
• Report Number: 1628664-2020-00078
• Device Sequence Number: 10947889
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 03/03/2020

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: 02/28/2021
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 55889UQ09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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 SYSTEM LN 03L77-97.; ARCHITECT C16000 SYSTEM.; LN 03L77-97, SERIAL (B)(6). ; SERIAL (B)(6).