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	04/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for section a1 - patient identifier: (b)(6).Complete entry for section e1 - phone number: (b)(6).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 reported falsely elevated total bilirubin on the architect c4000 processing module for two patients.The following results were provided: sid (b)(6) (b)(6) 2024 initial total bilirubin result= 2.15 mg/dl; (b)(6) 2024 repeat results= 0.85 and 0.84 mg/dl sid (b)(6) (b)(6) 2024 initial total bilirubin result= 2.09 mg/dl; (b)(6) 2024 repeat results= 0.56 and 0.56 mg/dl.There was no impact to patient management 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, 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.The search for similar complaints for lot 64808uq08 did not identify an increase in complaint activity for the issue.The ticket trending review did not identify any related trends regarding commonalities and issue.Device history record review performed on lot 64808uq08 did not show any potential non-conformances, deviations, or non-conformances.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the total bilirubin lot 64808uq08 was identified.
Event or Problem Description
The customer reported falsely elevated total bilirubin on the architect c4000 processing module for two patients.The following results were provided: sid (b)(6) , on (b)(6) 2024 initial total bilirubin result= 2.15 mg/dl; on (b)(6) 2024 repeat results= 0.85 and 0.84 mg/dl.Sid (b)(6), on (b)(6) 2024 initial total bilirubin result= 2.09 mg/dl; on (b)(6) 2024 repeat results= 0.56 and 0.56 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: 19341838
• Report Number: 3002809144-2024-00146
• Device Sequence Number: 8740032
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: (01)00380740174965(17)250131(10)64808UQ08
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: 06L45-22
• Device Lot Number: 64808UQ08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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