MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C TOTAL BILIRUBIN REAGENT KIT; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	04V51-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated alinity c total bilirubin for multiple patients.The following results were provided (reference range 0.4 ¿ 2.0 mg/dl): on (b)(6) 2025, initial total bilirubin result= 5.7 mg/dl, repeat result= 1.1 mg/dl, on (b)(6) 2025, initial total bilirubin result= 3 mg/dl, repeat result= 0.5 mg/dl, on (b)(6) 2025, initial total bilirubin result= 2.3 mg/dl, repeat result= 0.2 mg/dl, on (b)(6) 2025, initial total bilirubin result= 4.3 mg/dl, repeat result= 0.7 mg/dl, on (b)(6) 2025, initial total bilirubin result= 5.7 mg/dl, repeat result= 1.1 mg/dl, on (b)(6) 2025, initial total bilirubin result= 3.5 mg/dl, repeat result= 0.3 mg/dl, on (b)(6) 2025, initial total bilirubin result= 4.4 mg/dl, repeat result= 0.8 mg/dl, on (b)(6) 2025, initial total bilirubin result= 2.8 mg/dl, repeat result= 0.4 mg/dl, on (b)(6) 2025, initial total bilirubin result= 2.1 mg/dl, repeat result= 0.3 mg/dl, on (b)(6) 2025, initial total bilirubin result= 3.7 mg/dl, repeat result= 0.5 mg/dl, on (b)(6) 2025, initial total bilirubin result= 2.4 mg/dl, repeat result= 0.4 mg/dl, on (b)(6) 2025, initial total bilirubin result= 4.8 mg/dl, repeat result= 0.8 mg/dl, on (b)(6)2025, initial total bilirubin result= 3.5 mg/dl, repeat result= 0.6 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending for the alinity c total bilirubin assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 66958uq09.A device history record review did not identify any nonconformances or deviations associated with the lot number 66958uq09 and complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity c total bilirubin reagent lot number 66958uq09 was identified.
Event or Problem Description
The customer observed falsely elevated alinity c total bilirubin for multiple patients.The following results were provided (reference range 0.4 ¿ 2.0 mg/dl): on (b)(6) 2025, initial total bilirubin result= 5.7 mg/dl, repeat result= 1.1 mg/dl, on (b)(6) 2025, initial total bilirubin result= 3 mg/dl, repeat result= 0.5 mg/dl, on (b)(6) 2025, initial total bilirubin result= 2.3 mg/dl, repeat result= 0.2 mg/dl, on (b)(6) 2025, initial total bilirubin result= 4.3 mg/dl, repeat result= 0.7 mg/dl, on (b)(6) 2025, initial total bilirubin result= 5.7 mg/dl, repeat result= 1.1 mg/dl, on (b)(6) 2025, initial total bilirubin result= 3.5 mg/dl, repeat result= 0.3 mg/dl, on (b)(6) 2025, initial total bilirubin result= 4.4 mg/dl, repeat result= 0.8 mg/dl, on (b)(6) 2025, initial total bilirubin result= 2.8 mg/dl, repeat result= 0.4 mg/dl, on (b)(6) 2025, initial total bilirubin result= 2.1 mg/dl, repeat result= 0.3 mg/dl, on (b)(6) 2025, initial total bilirubin result= 3.7 mg/dl, repeat result= 0.5 mg/dl, on (b)(6) 2025, initial total bilirubin result= 2.4 mg/dl, repeat result= 0.4 mg/dl, on (b)(6) 2025, initial total bilirubin result= 4.8 mg/dl, repeat result= 0.8 mg/dl, on (b)(6) 2025, initial total bilirubin result= 3.5 mg/dl, repeat result= 0.6 mg/dl.There was no impact to patient management reported.

• Brand Name: ALINITY C TOTAL BILIRUBIN REAGENT KIT
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21241734
• Report Number: 3002809144-2025-00022
• Device Sequence Number: 8440019
• Product Code: CIG
• UDI-Device Identifier: 00380740158422
• UDI-Public: (01)00380740158422(17)260228(10)66958UQ09
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/07/2025

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: 02/28/2026
• Device Catalogue Number: 04V51-31
• Device Lot Number: 66958UQ09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown