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

Catalog Number	06L45-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
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.Completed information for section a1 patient identifier: (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed total bilirubin results generated on the architect c8000 processing module for multiple samples.The following example results were provided: (b)(6) 2023, sid (b)(6), initial result = < 1.7 umol/l, repeat result = 2.54 umol/l.Additionally, the following precision test was performed with the following results: 5.69 umol/l, 5.43 umol/l, 5.43 umol/l, 5.26 umol/l, 5.21 umol/l no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed total bilirubin results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Data and information provided by the customer were reviewed and support the complaint issue.Return testing was not completed as returns were not available.Ticket search by lots indicates that the reagent lots performs as expected for this product.Trending review did not identify any trends for the issue for the product.The device history record review did not identify any non-conformances or deviations with lot number 62588uq08 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Customer field data was used to assess the performance of the total bilirubin assay using worldwide data.Review shows that the median patient result for lot 62588uq08 is within established limits and comparable with other lots in the field, confirming no systemic issue for lot 62588uq08.Based on the investigation, no systemic issue or deficiency with the total bilirubin assay for lot 62588uq08 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed total bilirubin results generated on the architect c8000 processing module for multiple samples.The following example results were provided: 24jul2023 sid (b)(6)initial result = < 1.7 umol/l, repeat result = 2.54 umol/l additionally, the following precision test was performed with the following results: 5.69 umol/l, 5.43 umol/l, 5.43 umol/l, 5.26 umol/l, 5.21 umol/l 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17548298
• Report Number: 3002809144-2023-00354
• Device Sequence Number: 6676546
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• 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): 09/14/2023

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: 01/31/2024
• Device Catalogue Number: 06L45-22
• Device Lot Number: 62588UQ08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• 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, C804691; ARC C8 PROC MOD, 01G06-11, C804691
• Patient Sex: Unknown