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

Model Number	6L45-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2023
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.Completed information for patient identification: sids (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated total bilirubin results generated on the architect c16000 processing module for multiple samples.The following results were provided: (customer normal range 0.2-1.2 mg/dl).Pt (b)(6) came into er on (b)(6) 2023 initial result = 4.5 mg/dl.Pt (b)(6) went home and the doctor called and questioned result.The doctor had the patient come back in today for redraw and results = 0.6 mg/dl,0.6 mg/dl.The customer then pulled sample from (b)(6) 2023 reran result= 0.8 mg/dl.The customer reported no incorrect treatment given or withheld based on initial result; however, extra hepatitis testing was added due to result.Customer then proceeded with rerunning other samples and found more discrepant results: additional results were provided: sid (b)(6) result= 3.2 mg/dl, repeat result =1.20 mg/dl, sid (b)(6) result=2.8 mg/dl, repeat result=0.5 mg/dl, sid (b)(6) result= 2.3 mg/dl, repeat result= 0.8 mg/dl, sid (b)(6) result= 4.0 mg/dl, repeat result= 0.3 mg/dl, sid (b)(6) result=4.0 mg/dl, repeat result= 0.6 mg/dl, sid (b)(6) result=4.8 mg/dl, repeat result=0.60 mg/dl, sid (b)(6) result=5.2 mg/dl, repeat result= 0.30 mg/dl, sid (b)(6) result=4.0 mg/dl, repeat result=0.5 mg/dl, sid (b)(6) result= 4.4 mg/dl, repeat result= 0.6 mg/dl, sid (b)(6) result=1.5 mg/dl, repeat result= 0.4 mg/dl, sid (b)(6) result=4.8 mg/dl, repeat result= 0.4 mg/dl, sid (b)(6) result=2.5 mg/dl, repeat result= 0.4 mg/dl, sid (b)(6) result=4.8 mg/dl, repeat result=0.5 mg/dl, sid (b)(6) result=5.6 mg/dl, repeat result= 1.10 mg/dl, sid (b)(6) result=4.4 mg/dl, repeat result=0.7 mg/dl, sid (b)(6) result=4.9 mg/dl, repeat result=0.5 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from total bilirubin reagent kit, list number 06l45-21 to architect c16000 processing module, list number 03l77-01.Mdr number 3016438761-2023-00235 has been submitted and all further information will be documented under that mdr number.H3 other text : after further evaluation, the suspect medical device was changed from total bilirubin reagent kit, list number 06l45-21 to architect c16000 processing module, list number 03l77-01.Mdr number 3016438761-2023-00235 has been submitted and all further information will be documented under that mdr number.
Event or Problem Description
The customer observed falsely elevated total bilirubin results generated on the architect c16000 processing module for multiple samples.The following results were provided: (customer normal range 0.2-1.2 mg/dl).Pt (b)(6) came into er on (b)(6) 2023 initial result = 4.5 mg/dl.Pt (b)(6) went home and the doctor called and questioned result.The doctor had the patient come back in today for redraw and results = 0.6 mg/dl,0.6 mg/dl.The customer then pulled sample from (b)(6) 2023 reran result= 0.8 mg/dl.The customer reported no incorrect treatment given or withheld based on initial result; however, extra hepatitis testing was added due to result.Customer then proceeded with rerunning other samples and found more discrepant results: additional results were provided: sid (b)(6) result= 3.2 mg/dl, repeat result =1.20 mg/dl.Sid (b)(6) result=2.8 mg/dl, repeat result=0.5 mg/dl.Sid (b)(6) result= 2.3 mg/dl, repeat result= 0.8 mg/dl.Sid (b)(6) result= 4.0 mg/dl, repeat result= 0.3 mg/dl.Sid (b)(6) result=4.0 mg/dl, repeat result= 0.6 mg/dl.Sid (b)(6) result=4.8 mg/dl, repeat result=0.60 mg/dl.Sid (b)(6) result=5.2 mg/dl, repeat result= 0.30 mg/dl.Sid (b)(6) result=4.0 mg/dl, repeat result=0.5 mg/dl.Sid (b)(6) result= 4.4 mg/dl, repeat result= 0.6 mg/dl.Sid (b)(6) result=1.5 mg/dl, repeat result= 0.4 mg/dl.Sid (b)(6) result=4.8 mg/dl, repeat result= 0.4 mg/dl.Sid (b)(6) result=2.5 mg/dl, repeat result= 0.4 mg/dl.Sid (b)(6) result=4.8 mg/dl, repeat result=0.5 mg/dl.Sid (b)(6) result=5.6 mg/dl, repeat result= 1.10 mg/d.L sid (b)(6) result=4.4 mg/dl, repeat result=0.7 mg/dl.Sid (b)(6) result=4.9 mg/dl, repeat result=0.5 mg/dl.No impact to patient management was reported.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16715878
• Report Number: 3016438761-2023-00195
• Device Sequence Number: 15269975
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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: 02/29/2024
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 62899UQ09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown