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

Catalog Number	04V51-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely decreased alinity c total bilirubin result for a 3-day-old patient.The following data was provided: sample id: (b)(6) initial result, on (b)(6), was 66.17 mmol/l, a new sample was collected from the patient later that same day, and the result was 249 mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for a falsely decreased alinity c total bilirubin result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.A review of tracking and trending for the product and the likely cause lot did not identify an increase in complaint activity.Return testing was not completed as returns were not available.Data provided for the patient showed that the retest result was acceptable.File samples were not tested, as the sample was retested, and acceptable result was produced.In addition, the quality controls were within range at the time of the incident.Manufacturing documentation was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency with the alinity c total bilirubin reagent, lot number 66607uq06, was identified.
Event or Problem Description
The customer observed a falsely decreased alinity c total bilirubin result for a 3-day-old patient.The following data was provided: sample id (b)(6) initial result, on 23dec, was 66.17 mmol/l, a new sample was collected from the patient later that same day, and the result was 249 mmol/l.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: 21201204
• Report Number: 3002809144-2025-00015
• Device Sequence Number: 7475867
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: (01)00380740158415(17)251130(10)66607UQ06
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 11/30/2025
• Device Catalogue Number: 04V51-21
• Device Lot Number: 66607UQ06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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 Age: 3 DA
• Patient Sex: Unknown