MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TACROLIMUS REAGENT KIT; ENZYME IMMUNOASSAY, TRACROLIMUS

Catalog Number	09P42-20
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 patient identifier complete information: (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 observed discrepant alinity i tacrolimus results for a patient with the date of birth on (b)(6) 2007.The following results were provided: the results were provided included multiple sids for the same patient.(customer provided tacrolimus reference range 5-15 ng/ml) on (b)(6) 2024, sid: (b)(6), result = <2.0 ng/ml, on (b)(6) 2024, result = 13.2 ng/ml, on (b)(6) 2024, result = 18.5 ng/ml, on (b)(6) 2024, result = 44.2 ng/ml, on (b)(6) 2024, result = 15.4 ng/ml, on (b)(6) 2024, result = 13.7 ng/ml, on (b)(6) 2024, result = 2.9 ng/ml, on (b)(6) 2024, result = 11.2 ng/ml, on (b)(6) 2024, result = 16.5 ng/ml, on (b)(6) 2024, result = 29.7 ng/ml, on (b)(6) 2024, result = 7.4 ng/ml, on (b)(6) 2024, result = 14.3 ng/ml, on (b)(6) 2024, result = 12.4 ng/ml, on (b)(6) 2024, result = 5.1 ng/ml, on (b)(6) 2024, result = 6.4 ng/ml, on (b)(6) 2024, result = 6.4 ng/ml, on (b)(6) 2024, result = 3.8 ng/ml, on (b)(6) 2024, result = 3.8 ng/ml, on (b)(6) 2024, result = 3.4 ng/ml, on (b)(6) 2024, result = 3.4 ng/ml, on (b)(6) 2024, result = 2.2 ng/ml, on (b)(6) 2024, result = 2.2 ng/ml, on (b)(6) 2024, result = 3.2 ng/ml, on (b)(6) 2024, result = 3.2 ng/ml, on (b)(6) 2024, result = <2 ng/ml, on (b)(6) 2024, result = 5.6 ng/ml, on (b)(6) 2024, result = 5.4 ng/ml, on (b)(6) 2024, result = 7.5 ng/ml, on (b)(6) 2024, result = 6.1 ng/ml, on (b)(6) 2024, result = 3.5 ng/ml, on (b)(6) 2024, result = 6.5 ng/ml, on (b)(6) 2024, result = 14.2 ng/ml, on (b)(6) 2024, result = <2.0 ng/ml, on (b)(6) 2024, result = <2.0 ng/ml, on (b)(6) 2024, sid: (b)(6), result = <2.0 ng/ml, on (b)(6) 2024, result = 5.2 ng/ml, on (b)(6) 2024, result = 8.5 ng/ml, on (b)(6) 2024, result = 17.7 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 7.8 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 27.7 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 3.6 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 20.4 ng/ml, on (b)(6) 2024, result = 11.3 ng/ml, on (b)(6) 2024, result = 10.5 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 6.0 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 10.6 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 5.3 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 2.1 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 4.8 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 8.7 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 6.0 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 4.3 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 6.6 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 6.9 ng/ml, on (b)(6) /2024, sid: (b)(6), result = 8.1 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 2.1 ng/ml , on (b)(6) 2024, sid: (b)(6), result = 2.1 ng/ml, on (b)(6) 2024, sid: (b)(6), result = 2.1 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for discrepant alinity i tacrolimus 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 in house testing.Data and information provided by the customer were reviewed.Return testing was not completed as returns were not available.The ticket search by lot indicates that the reagent lot performs as expected for this product.The ticket trending review did not identify an increase in complaint activity.In house accuracy testing was completed with a retained kit of the complaint lot.All validity and acceptance criteria were met, which indicates acceptable product performance.Customer issue was not confirmed.Device history review was performed on lot 65269fp00, which did not show any potential non-conformances, deviations, or non-conformances.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity i tacrolimus reagent lot 65269fp00 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed discrepant alinity i tacrolimus results for a patient with the date of birth (b)(6) 2007.The following results were provided: the results were provided included multiple sids for the same patient.(customer provided tacrolimus reference range 5-15 ng/ml) on (b)(6) 2024, sid (b)(6) result = <2.0 ng/ml.On (b)(6) 2024 result = 13.2 ng/ml, on (b)(6) 2024 result = 18.5 ng/ml, on (b)(6) 2024 result = 44.2 ng/ml, on (b)(6) 2024 result = 15.4 ng/ml, on (b)(6) 2024 result = 13.7 ng/ml, on (b)(6)2024 result = 2.9 ng/ml, on (b)(6)2024 result = 11.2 ng/ml, on (b)(6) 2024 result = 16.5 ng/ml, on (b)(6) 2024 result = 29.7 ng/ml, on (b)(6) 2024 result = 7.4 ng/ml, on (b)(6) 2024 result = 14.3 ng/ml, on (b)(6) 2024 result = 12.4 ng/ml, on (b)(6) 2024 result = 5.1 ng/ml, on (b)(6) 2024 result = 6.4 ng/ml, on (b)(6) 2024 result = 6.4 ng/ml, on (b)(6) 2024 result = 3.8 ng/ml, on (b)(6) 2024 result = 3.8 ng/ml, on (b)(6) 2024 result = 3.4 ng/ml, on (b)(6) 2024 result = 3.4 ng/ml, on (b)(6) 2024 result = 2.2 ng/ml, on (b)(6) 2024 result = 2.2 ng/ml, on (b)(6) 2024 result = 3.2 ng/ml, on (b)(6) 2024 result = 3.2 ng/ml, on (b)(6) 2024 result = <2 ng/ml, on (b)(6) 2024 result = 5.6 ng/ml, on (b)(6) 2024 result = 5.4 ng/ml, on (b)(6) 2024 result = 7.5 ng/ml, on (b)(6) 2024 result = 6.1 ng/ml, on (b)(6) 2024 result = 3.5 ng/ml, on (b)(6) 2024 result = 6.5 ng/ml, on (b)(6) 2024 result = 14.2 ng/ml, on (b)(6) 2024 result = <2.0 ng/ml, on (b)(6) 2024 result = <2.0 ng/ml, on (b)(6) 2024, sid (b)(6) result = <2.0 ng/ml, on (b)(6) 2024 result = 5.2 ng/ml, on (b)(6) 2024 result = 8.5 ng/ml, on (b)(6) 2024 result = 17.7 ng/ml, on (b)(6) 2024, sid (b)(6) result = 7.8 ng/ml, on (b)(6) 2024, sid (b)(6) result = 27.7 ng/ml, on (b)(6) 2024, sid (b)(6) result = 3.6 ng/ml, on (b)(6) 2024, sid (b)(6) result = 20.4 ng/ml, on (b)(6) 2024 result = 11.3 ng/ml, on (b)(6) 2024 result = 10.5 ng/ml.On (b)(6) 2024, sid (b)(6), (b)(6) result = 6.0 ng/ml, on (b)(6) 2024, sid (b)(6), (b)(6) result = 10.6 ng/ml, on (b)(6) 2024, sid (b)(6) result = 5.3 ng/ml, on (b)(6) 2024, sid (b)(6) result = 2.1 ng/ml, on (b)(6) 2024, sid (b)(6) result = 4.8 ng/ml, on (b)(6) 2024, sid (b)(6) result = 8.7 ng/ml, on (b)(6) 2024, sid (b)(6) result = 6.0 ng/ml, on (b)(6) 2024, sid (b)(6), (b)(6) result = 4.3 ng/ml, on (b)(6) 2024, sid (b)(6), (b)(6) result = 6.6 ng/ml, on (b)(6) 2024, sid (b)(6) result = 6.9 ng/ml, on (b)(6) 2024, sid (b)(6), (b)(6) result = 8.1 ng/ml, on (b)(6) 2024, sid (b)(6), (b)(6) result = 2.1 ng/ml, on (b)(6) 2024, sid (b)(6), (b)(6) result = 2.1 ng/ml, on (b)(6) 2024 sid (b)(6), (b)(6) result = 2.1 ng/ml.No impact to patient management was reported.

• Brand Name: ALINITY I TACROLIMUS REAGENT KIT
• Common Device Name: ENZYME IMMUNOASSAY, TRACROLIMUS
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20923553
• Report Number: 3008344661-2024-00152
• Device Sequence Number: 17466413
• Product Code: MLM
• UDI-Device Identifier: 00380740154516
• UDI-Public: (01)00380740154516(17)251104(10)65269FP00
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K070820
• 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): 02/06/2025

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: 11/04/2025
• Device Catalogue Number: 09P42-20
• Device Lot Number: 65269FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 16 YR
• Patient Sex: Unknown