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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false elevated total bilirubin results when processing on the architect c16000.The following initial and retest data was provided: 18.1 (initial) and 12.6 (retest).53.5 (initial) and 40.8 (retest).5.3 (initial) and 3.7 (retest).25 (initial) and 19.6 (retest).The customer uses a reference range of 3.4-20.5 umol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of trending data, a review of manufacturing documentation, and a review of product labeling.A ticket search by product lot found one complaint similar to the current complaint issue.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 manufacturing documentation for the likely cause lot did not identify any issues.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not 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: 9573658
• Report Number: 1628664-2020-00013
• Device Sequence Number: 11523818
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/28/2020

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: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 55286UQ05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 02/28/2020
• 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, LIST 03L77-01.; ARCHITECT C16000, LIST 03L77-01.; SERIAL (B)(6) .; SERIAL (B)(6) .