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

Catalog Number	06L45-42
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed increased total bilirubin results generated on the architect c8000 analyzer for 13 patients.The customer repeated the samples on another architect which generated lower results.The following data was provided: sid (b)(6) initial result = 1.54 repeat result = 0.59.Sid (b)(6) initial result = 0.7 repeat result = 0.3.Sid (b)(6) initial result = 0.8 repeat result = 0.4.Sid (b)(6) initial result = 0.6 repeat result = 0.3.Sid (b)(6) initial result = 0.9 repeat result = 0.4.Sid (b)(6) initial result = 0.9 repeat result = 0.4.Sid (b)(6) initial result = 4.1 repeat result = 1.6.Sid (b)(6) initial result = 0.8 repeat result = 0.5.Sid (b)(6) initial result = 2.9 repeat result = 1.2.Adult ref range 0.2-1.2 mg/dl.The following samples are neonates reference range is 6-10.5 mg/dl.Sid (b)(6) initial result = 14.9 repeat result = 5.6.Sid (b)(6) initial result = >25.0 repeat result = 8.35.Sid (b)(6) initial result = 15.9 repeat result = 6.2.Sid (b)(6) initial result = 22.2 repeat result = 8.6 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.Complete information for section a1 patient identifier = (b)(6).
Event or Problem Description
The customer observed increased total bilirubin results generated on the architect c8000 analyzer for 13 patients.The customer repeated the samples on another architect which generated lower results.The following data was provided: sid (b)(6), initial result = 1.54 repeat result = 0.59.Sid (b)(6), initial result = 0.7 repeat result = 0.3.Sid(b)(6), initial result = 0.8 repeat result = 0.4.Sid(b)(6), initial result = 0.6 repeat result = 0.3.Sid (b)(6), initial result = 0.9 repeat result = 0.4.Sid (b)(6), initial result = 0.9 repeat result = 0.4.Sid (b)(6), initial result = 4.1 repeat result = 1.6.Sid (b)(6), initial result = 0.8 repeat result = 0.5.Sid(b)(6), initial result = 2.9 repeat result = 1.2.Adult ref range 0.2-1.2 mg/dl.The following samples are neonates reference range is 6-10.5 mg/dl sid (b)(6), initial result = 14.9 repeat result = 5.6.Sid (b)(6), initial result = >25.0 repeat result = 8.35.Sid (b)(6), initial result = 15.9 repeat result = 6.2.Sid (b)(6), initial result = 22.2 repeat result = 8.6 no impact to patient management was reported.
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.Issue was cause by bubbles in the reagent.Issue was resolved by changing cartridge and calibrating.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.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 architect total bilirubin reagent lot 64715uq08 was identified.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19811166
• Report Number: 3016438761-2024-00423
• Device Sequence Number: 18237635
• Product Code: CIG
• UDI-Device Identifier: 00380740174972
• UDI-Public: (01)00380740174972(17)250131(10)64715UQ08
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 07/09/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/26/2024
• 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, (B)(6); ARC C8 PROC MOD, 01G06-11, (B)(6)
• Patient Sex: Unknown