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

Catalog Number	06L45-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely depressed total bilirubin result generated on the architect c4000 processing module for one patient.The following data was provided: sid: (b)(6) total bilirubin result was <1.8 umol/l, repeat on an alinity at another laboratory = 5.8 umol/l and 7.7 umol/l.Additional laboratory results were provided: direct bilirubin result = 35 umol/l, repeat on an alinity at another laboratory = 25.8 umol/l and 33.5 umol/l.Igm results = 101.6 and 97.7.No impact to patient management was reported.
Additional Manufacturer Narrative
Completed information for section a1 patient identifier: sid (b)(6).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, labeling review, and device history record 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 without indication for any additional issue.Review of tracking and trending for the 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 66449uq06.Device history review did not identify any non-conformances or deviations with lot number 66449uq06 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the total bilirubin reagent lot 66449uq06 was identified.
Event or Problem Description
The customer observed a falsely depressed total bilirubin result generated on the architect c4000 processing module for one patient.The following data was provided: sid (b)(6): total bilirubin result was <1.8 umol/l, repeat on an alinity at another laboratory = 5.8 umol/l and 7.7 umol/l.Additional laboratory results were provided: direct bilirubin result = 35 umol/l, repeat on an alinity at another laboratory = 25.8 umol/l and 33.5 umol/l.Igm results = 101.6 and 97.7.No impact to patient management was reported.

• Brand Name: TOTAL BILIRUBIN
• 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: 21395105
• Report Number: 3002809144-2025-00042
• Device Sequence Number: 8274161
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: (01)00380740174965(17)251130(10)66449UQ06
• 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): 03/13/2025

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: 06L45-22
• Device Lot Number: 66449UQ06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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: ARC C4000 INT REF SEKAT, 01R25-97, (B)(6); ARC C4000 INT REF SEKAT, 01R25-97, (B)(6)
• Patient Sex: Unknown