MAUDE Adverse Event Report: ABBOTT LABORATORIES TOTAL BILIRUBIN; DIAZO COLORIMETRY, BILIRUBIN

Model Number	6L45-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2020
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.Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely decreased total bilirubin results for several patients on an architect c4000 analyzer.The following data was provided (customer¿s reference range is 0.20-1.20 mg/dl): sample id (b)(6) initial result was <0.2, repeat was 0.55 mg/dl.Sample id (b)(6) initial result was <0.2, repeat was 0.40 mg/dl.Sample id (b)(6) initial result was <0.2, repeat was 0.33 mg/dl.Sample id (b)(6) initial result was 0.79, repeat was 1.40 mg/dl.Sample id (b)(6) initial result was 0.64, repeat was 1.24 mg/dl.Sample id (b)(6) initial result was <0.2, repeat was 0.59 mg/dl.Sample id (b)(6) initial result was <0.2, repeat was 0.32 mg/dl.Sample id (b)(6) initial result was <0.2, repeat was 0.48 mg/dl.Sample id (b)(6) initial result was <0.2, repeat was 0.30 mg/dl.Sample id (b)(6) initial result was 0.35, repeat was 0.95 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
Health effect impact code: f26.Component code: g01003.D8.Was this device serviced by a third party? no.The complaint investigation for falsely decreased total bilirubin results, while using total bilirubin reagent list number 06l45, lot number 56466uq12, calibrated with bilirubin calibrator list number 01e66, lot number 31253fd01, included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.A review of complaint activity determined that there is no atypical complaint activity for lot number 56466uq12.Trending review determined no related trend for falsely elevated results for the product.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.Manufacturing documentation for the likely cause lots were reviewed and did not identify any issues.The overall performance of the total bilirubin reagent, lot number 56466uq12, was reviewed using data gathered via abbottlink from customers worldwide and suggested that the performance is acceptable.Based on all available information and abbott diagnostics' complaint investigation, no product deficiency was identified.
Additional Manufacturer Narrative
Concomitant product added to section d11.
Additional Manufacturer Narrative
This follow up is submitted, to populate fields d8 and/or h6 with data, that had previously been provided in field h10.There is no change to the content of the data.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 11227009
• Report Number: 3016438761-2021-00025
• Device Sequence Number: 3512873
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/27/2021

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: 05/31/2021
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 56466UQ12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 12/31/2020; 03/01/2021; 05/26/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 01/26/2021; 03/10/2021; 05/27/2021
• 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: ARC C4000 INTGR, 02P24-40, C401603; ARC C4000 INTGR, 02P24-40, C401603; ARC C4000 INTGR, 02P24-40, C401603