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

Catalog Number	06L45-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.Patient identifier sid's: (b)(6).
Event or Problem Description
The customer reported a falsely elevated neonatal total bilirubin result generated on the architect c4000 analyzer on one patient.Results provided: (b)(6) 2019 architect vitros alinity.Sid (b)(6) drawn 1004 = 18.2 /16.0 /16.7.Sid (b)(6) drawn 1635 = 18.3 / 15.6 /16.7.Sid (b)(6) drawn 2315 = 19.4 / 16.0 / 17.5 / repeat on architect = 19.5.Normal range: 0.2 to 12.0 mg/dl.Sister hospital vitros result on (b)(6) 2019 = 13.4 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The evaluation of complaint data for the likely cause architect total bilirubin assay lot 54457uq01 identified one similar complaint that was closed to no deficiency.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: 9244234
• Report Number: 1628664-2019-00681
• Device Sequence Number: 16657815
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K060574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: 06/30/2020
• Device Catalogue Number: 06L45-21
• Device Lot Number: 54457UQ01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/06/2019
• 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 C4000 ANALYZER LIST 02P24-40; ARCHITECT C4000 ANALYZER LIST 02P24-40; SERIAL (B)(4); SERIAL (B)(4)