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)
Date of Event	03/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: multiple = (b)(6).There is no further patient information provided due to privacy issues.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated total bilirubin results on two patients generated on the architect analyzer.The results provided were: sid (b)(6) initial = 152.2 / repeat 6.0umol/l; sid (b)(6) initial = 110.9 / repeat =13.3umol//l.The medic questioned the results prior to clinical decisions being made.There was no reported impact to patient management.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from total bilirubin, list number 06l45-41, abbott manufacturing inc 1921 hurd drive, irving, tx 75038, usa in section d of this report to architect c16000 system, ln 03l77-01 abbott manufacturing inc 1921 hurd drive, irving, tx 75038, usa.Mdr number 1628664-2019-00347 has been submitted and all further information will be documented under that mdr number.

• 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: 8475150
• Report Number: 1628664-2019-00280
• Device Sequence Number: 13933302
• 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): 04/29/2019

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: 04/30/2020
• Device Catalogue Number: 06L45-41
• Device Lot Number: 54131UQ11
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/29/2019
• 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 # C1600373; SERIAL # C1600373