MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY TOTAL BILIRUBIN

Catalog Number	06L45-41
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for patient information, patient identifier, multiple = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no further patient information provided by the customer.
Event or Problem Description
The customer reported that they are observing falsely elevated total bilirubin on their architect compared to what their sister site is getting on both patient results and controls.The example results provided were for 2 adult patients: (b)(6) on (b)(6) 2018 =1.9mg/dl (range = 0-1.2mg/dl) / sample sent to arup = 1.1 / previously on (b)(6) 2017 by roche = 1.3; (b)(6) on (b)(6) 2018 = 2.3mg/dl / sent to arup = 1.4 / previously in 2017 = 0.8 (unknown method).There was no reported impact to patient management.
Additional Manufacturer Narrative
Correction to section suspect medical device, 4.Catalog # from 07p32-21 to 06l45-41 and the udi # from (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
A review of tickets found no other complaints similar to the current complaint issue.The trend review by the product list number found no trends related to this issue.Return testing was not completed as returns were not available.Historical performance in the field of reagent lot 52656uq02 using world wide data through abbottlink was evaluated.The patient data in the field for the past year shows the total bilirubin patient population result median for the complaint reagent lot 52656uq02 and calibrator lot 43867fd01 is similar and within 1 sd of the overall median.This data suggests the total bilirubin product is performing as intended.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling concluded that the issue is adequately addressed.Based on the investigation no product deficiency was identified for the clinical chemistry total bilirubin, lot 52656uq02.

• Brand Name: CLINICAL CHEMISTRY TOTAL BILIRUBIN
• Common Device Name: TOTAL BILIRUBIN
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8101461
• Report Number: 1628664-2018-02032
• Device Sequence Number: 1057826
• Product Code: CIG
• UDI-Device Identifier: 00380740129033
• UDI-Public: 00380740129033
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2019

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: 07/31/2019
• Device Catalogue Number: 06L45-41
• Device Lot Number: 52656UQ02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/26/2018; 01/11/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 12/13/2018; 01/16/2019
• 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 C8000 SYSTEM, LIST # 01G06-11,; ARCHITECT C8000 SYSTEM, LIST # 01G06-11,; ARCHITECT C8000 SYSTEM, LIST # 01G06-11,; SERIAL # (B)(4); SERIAL # (B)(4); SERIAL # (B)(4)