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	03/14/2024
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 a patient.The same sample was tested on the roche platform and a lower result was obtained.As part of troubleshooting, the assay was recalibrated and the same sample generated a normal result post recalibration.The following data was provided: customer¿s normal range: 0.2 to 1.20 mg/dl.Initial result = 1.97 mg/dl.Repeat result post recalibration = 1.08 mg/dl.Roche platform result = 1.01 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 a patient.The same sample was tested on the roche platform and a lower result was obtained.As part of troubleshooting, the assay was recalibrated and the same sample generated a normal result post recalibration.The following data was provided: customer¿s normal range: 0.2 to 1.20 mg/dl.Initial result = 1.97 mg/dl.Repeat result post recalibration = 1.08 mg/dl.Roche platform result = 1.01 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated total bilirubin result 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.Ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 63608uq02 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.In addition, the quality control result was acceptable and within the expected range during the time the discrepant result was generated which indicates the acceptable performance of the reagent on the instrument.Based on our investigation, no systemic issue or deficiency with the total bilirubin assay for lot 63608uq02 was identified.

• 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: 19016608
• Report Number: 3002809144-2024-00088
• Device Sequence Number: 17113677
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: (01)00380740174965(17)240731(10)63608UQ02
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 05/15/2024

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: 07/31/2024
• Device Catalogue Number: 06L45-22
• Device Lot Number: 63608UQ02
• 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: 03/16/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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, (B)(4) ; ARC C4000 INTGR, 02P24-40, (B)(4)
• Patient Sex: Unknown