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

Model Number	6L45-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased total bilirubin results generated on the architect c4000 analyzer for three patients after switching to a new lot of bilirubin calibrator.The customer also noted a downward shift on quality controls and one of the three control levels were out of range.The customer believed the results from the old calibrator were correct.The following data was provided: total bilirubin normal patient ranges: 3.4 to 20.5 umol/l.Sid (b)(6): result (new calibrator) = 17.4 umol/l; result (old calibrator) = 23.9 umol/l.Sid (b)(6): result (new calibrator) = 18.9 umol/l; result (old calibrator) = 24.8 umol/l.Sid (b)(6): result (new calibrator) = 18.6 umol/l; result (old calibrator) = 27.3 umol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Patient identifiers: sids = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Section d10 - concomitant product: additional product added: cc bilirubin cal(6x5ml),01e66-05,97449fd01.The complaint investigation for falsely decreased total bilirubin results, while using total bilirubin reagent lot 62321uq07 with architect bilirubin calibrator lot 97449fd01, included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history records 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 the likely cause lot and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.All release criteria were met and the product continues to perform within specifications.However, a notification letter was provided to customers to explain the potential for lower recovery in total bilirubin results when using architect bilirubin calibrator specific lot numbers (including lot 97449fd01 in use at the customer site).The architect bilirubin calibrator lot 97449fd01 is performing as expected.Based on our investigation, no systemic issue or deficiency was identified for the total bilirubin reagent lot 62321uq07 when used with architect bilirubin calibrator lot 97449fd01.

• 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: 16384927
• Report Number: 3002809144-2023-00087
• Device Sequence Number: 5605458
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

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: 12/31/2023
• Device Model Number: 6L45-22
• Device Catalogue Number: 06L45-22
• Device Lot Number: 62321UQ07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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 C4 PROC MOD, 02P24-01, (B)(6); ARC C4 PROC MOD, 02P24-01, (B)(6); CC BILIRUBIN CAL(6X5ML), 01E66-05, 97449FD01
• Patient Sex: Unknown