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)
Date of Event	06/10/2024
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 falsely decreased total bilirubin results for numerous patients on an architect c4000 analyzer.The following data was provided (customer¿s reference range is 0.2-1.2 mg/dl): initial result, on (b)(6) 2024, was <0.1, repeat, on same analyzer, was <0.1, repeat, on another analyzer, was 0.4 mg/dl.The customer provided results for additional samples with sample ids ranging from 1 to 28 with initial results ranging from <0.1 to 0.9 and repeat results, on another analyzer, ranging from 0.2 to 1.4 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
Section a1 - patient identifier complete entry = see section b5.The complaint investigation for falsely decreased total bilirubin results included a review of data and information provided by the customer, ticket trending review, labeling review, and device history record review.Trending review determined no related trend for falsely elevated results for the product.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.Manufacturing documentation for the likely cause list number were reviewed and did not identify any issues.File samples were not tested, as the samples were retested on another instrument with the same reagent lot, and acceptable result was produced.In addition, the quality controls were performing within the expected ranges, which shows that the assays were performing as expected.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency with the total bilirubin reagent, lot number 64715uq08, was identified.
Event or Problem Description
The customer observed falsely decreased total bilirubin results for numerous patients on an architect c4000 analyzer.The following data was provided (customer¿s reference range is 0.2-1.2 mg/dl): initial result, on (b)(6) 2024, was <0.1, repeat, on same analyzer, was <0.1, repeat, on another analyzer, was 0.4 mg/dl.The customer provided results for additional samples with sample ids ranging from 1 to 28 with initial results ranging from <0.1 to 0.9 and repeat results, on another analyzer, ranging from 0.2 to 1.4 mg/dl.There was no impact to patient management 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: 19650950
• Report Number: 3002809144-2024-00190
• Device Sequence Number: 6550092
• Product Code: CIG
• UDI-Device Identifier: 00380740174972
• UDI-Public: (01)00380740174972(17)250131(10)64715UQ08
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/17/2024

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): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/17/2024
• 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 C4000 INTGR, 02P24-40, (B)(6); ARC C4000 INTGR, 02P24-40, (B)(6)
• Patient Sex: Unknown