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

Catalog Number	06L45-41
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
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.
Event or Problem Description
The customer reported falsely elevated total bilirubin on one patient generated on the architect analyzer.The results provided were: sid (b)(6) = 107umol/l / repeated on different analyzer = 8.5 (reference range = <25umol/l).There was no reported impact to patient management.
Additional Manufacturer Narrative
A search for similar complaints for the total bilirubin reagent (ln 6l45-41) lot 54494uq01 did not identify any additional complaints and no trends were identified for the product issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the total bilirubin reagent, lot 54494uq01.

• 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: 8587548
• Report Number: 1628664-2019-00357
• Device Sequence Number: 19216696
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: 06L45-41
• Device Lot Number: 54494UQ01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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 C16000 SYSTEM, LN 03L77-01; ARCHITECT C16000 SYSTEM:LN 03L77-01:; SERIAL # (B)(4); SN (B)(4); ARCHITECT C16000 SYSTEM: LN 03L77-01; SN (B)(4)