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	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for patient information, patient identifier: multiple = (b)(6).All available patient information was included.Additional patient details are not 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 falsely elevated total bilirubin results were generated for neonates while using the architect c461216 analyzer.The following results were provided: sid: (b)(6) - architect: 17.8 mg/dl; alternate method: 13.9 mg/dl (% shift = 28%).Sid: (b)(6) - architect: 10.2 mg/dl; alternate method: 8.3 mg/dl (% shift = 22.9%).The customer further stated that sid: (b)(6) generated an architect result of 15.2 mg/dl, with a alternate method result of 12.3 mg/dl (% shift = 23.6%); however, the customer was not sure if the architect result was generated on the c461216 or the c401829 analyzer.The customer was utilizing a critical cut off of >/= 17 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
A search for similar complaints for the total bilirubin reagent lot 53810uq09 did not identify any similar complaints for the customer's issue.Return testing was not completed as returns were not available.Tracking and trending did not identify any trends associated with the product issue.The historical performance of reagent lot 53810uq09 was evaluated using world wide data and the evaluation indicated that the patient median result for lot 53810uq09 is within the established control limits.No unusual reagent lot performance was identified.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Review of product labeling found adequate information regarding the issue.Based on the investigation no product deficiency was identified for the total bilirubin reagent, lot 53810uq09.

• 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: 8623836
• Report Number: 1628664-2019-00390
• Device Sequence Number: 11263885
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/23/2019

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: 02/29/2020
• Device Catalogue Number: 06L45-21
• Device Lot Number: 53810UQ09
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 07/14/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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 # 02P24-01; ARCHITECT C4000 ANALYZER, LN 02P24-01; SERIAL # (B)(4); SN C461216; ARCHITECT C4000 ANALYZER, LN 02P24-01; SN: (B)(4)