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

Catalog Number	06L45-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
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.
Event or Problem Description
The customer observed falsely elevated total bilirubin result generated on the architect c4000 processing module for one patient.The customer replaced the reagent, performed calibration, and repeated the sample which generated a normal result.The following data was provided: customer¿s normal range: 0.2 to 1.2 mg/dl patient 1: initial result: 1.26 mg/dl, repeat result = 0.5 mg/dl.There was no impact to patient management reported.
Event or Problem Description
The customer observed falsely elevated total bilirubin result generated on the architect c4000 processing module for one patient.The customer replaced the reagent, performed calibration, and repeated the sample which generated a normal result.The following data was provided: customer¿s normal range: 0.2 to 1.2 mg/dl.(b)(6): initial result = 1.26 mg/dl, repeat result = 0.5 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
Section d10: concomitant product: cc bilirubin cal(6x5ml),01e66-05,24908fd01 was removed.The complaint investigation included a review of data and information provided by the customer, a search for similar complaints, a ticket trending review, a device history record review, and a labeling review.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and supported the complaint issue.A ticket search by lot did not identify an increase in complaint activity related to the issue under review.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot number 65437uq12 and the complaint.Labeling was reviewed and sufficiently addresses the customer's issue.The customer performed troubleshooting by replacing the reagent with a kit of the same lot, recalibrating the assay, and repeating the sample, which generated a normal result.The quality control value was within range.Based on our investigation, no systemic issue or deficiency was identified with the total bilirubin reagent, lot number 65437uq12.

• 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: 20737949
• Report Number: 3002809144-2024-00330
• Device Sequence Number: 8614333
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: (01)00380740174965(17)250531(10)65437UQ12
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: 05/31/2025
• Device Catalogue Number: 06L45-22
• Device Lot Number: 65437UQ12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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 INTGR, 02P24-40, C401430; ARC C4000 INTGR, 02P24-40, C401430; CC BILIRUBIN CAL(6X5ML), 01E66-05, 24908FD01
• Patient Sex: Unknown