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

Model Number	6L45-42
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated total bilirubin results generated on the architect c4000 processing module for multiple samples from newborns.The results are 20-25% higher when compared to other methods.The following example data was provided.(b)(6) 2022 sid (b)(6), initial result = 438.8 umol/l, repeat on roche = 341.6 umol/l.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.
Additional Manufacturer Narrative
The complaint investigation for elevated 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.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 59393uq04 and the complaint issue.The overall performance of total bilirubin assay was reviewed using field data from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 59393uq04 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 59393uq04.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the total bilirubin reagent for lot 59393uq04 was identified.Section d4 catalog no was updated from 06l45-42 to 06l45-22.

• 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: 14596862
• Report Number: 3002809144-2022-00185
• Device Sequence Number: 20184478
• Product Code: CIG
• UDI-Device Identifier: 00380740174972
• UDI-Public: 00380740174972
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 07/03/2022

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: 09/30/2022
• Device Model Number: 6L45-42
• Device Catalogue Number: 06L45-22
• Device Lot Number: 59393UQ04
• 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: 05/16/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 07/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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 INT REF SEKAT, 01R25-97, (B)(6) ; ARC C4000 INT REF SEKAT, 01R25-97, (B)(6)
• Patient Sex: Unknown