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

Catalog Number	06L45-42
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased total bilirubin results generated on the architect c8000 processing module for multiple samples.The customer observed initial results < 0.1 mg/dl, but all patients reran were within normal range.The following example results were provided: (customer provided normal range: 0.2-1.3 mg/dl) initial result: <0.1 mg/dl, repeat result 0.2 mg/dl initial result: <0.1 mg/dl, repeat result 0.3 mg/dl initial result: <0.1 mg/dl, repeat result 0.4 mg/dl initial result: <0.1 mg/dl, repeat result 0.4 mg/dl initial result: <0.1 mg/dl, repeat result 0.4 mg/dl initial result: <0.1 mg/dl, repeat result 0.2 mg/dl initial result : <0.1 mg/dl, repeat result 0.4 mg/dl initial result: <0.1 mg/dl, repeat result 0.3 mg/dl initial result: <0.1 mg/dl, repeat result 0.3 mg/dl initial result : <0.1 mg/dl, repeat result 0.2 mg/dl no impact to patient management was 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
Updated information in section d4 - expiration date and d4 - primary udi number the complaint investigation for falsely decreased total bilirubin results generated on the architect c8000 processing module 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.Review of all the information provided by the customer was reviewed.A review of tracking and trending did not identify any trends for the complaint issue.A ticket search by the total bilirubin lot number 64715uq08 did not identify an increase in complaint activity related to the issue under review.Device history review did not identify any non-conformances or deviations with the complaint lot.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 64715uq08 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely decreased total bilirubin results generated on the architect c8000 processing module for multiple samples.The customer observed initial results < 0.1 mg/dl, but all patients reran were within normal range.The following example results were provided: (customer provided normal range: 0.2-1.3 mg/dl).Initial result: <0.1 mg/dl, repeat result 0.2 mg/dl.Initial result: <0.1 mg/dl, repeat result 0.3 mg/dl.Initial result: <0.1 mg/dl, repeat result 0.4 mg/dl.Initial result: <0.1 mg/dl, repeat result 0.4 mg/dl.Initial result: <0.1 mg/dl, repeat result 0.4 mg/dl.Initial result: <0.1 mg/dl, repeat result 0.2 mg/dl.Initial result : <0.1 mg/dl, repeat result 0.4 mg/dl.Initial result: <0.1 mg/dl, repeat result 0.3 mg/dl.Initial result: <0.1 mg/dl, repeat result 0.3 mg/dl.Initial result : <0.1 mg/dl, repeat result 0.2 mg/dl.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: 19446955
• Report Number: 3002809144-2024-00162
• Device Sequence Number: 8544928
• Product Code: CIG
• UDI-Device Identifier: 00380740174972
• UDI-Public: (01)00380740174972(17)250131(10)64715UQ08
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/13/2024

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: 01/31/2025
• Device Catalogue Number: 06L45-42
• Device Lot Number: 64715UQ08
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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 C8 PROC MOD, 01G06-11, C803882, C803278; ARC C8 PROC MOD, 01G06-11, C803882, C803278; CC BILIRUBIN CAL(6X5ML), 01E66-05, 24908FD01; CC BILIRUBIN CAL(6X5ML), 01E66-05, 24908FD01
• Patient Sex: Unknown