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

Catalog Number	09P42-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported falsely elevated alinity i tacrolimus result generated on the alinity i processing module for a patient.The result was released out of the lab.The following data was provided: patient 1: on (b)(6) 2024, sid (b)(6) first result = 7.1 ng/ml.On (b)(6) 2024, sid (b)(6) second result = 12 ng/ml.The customer stated that due to the falsely elevated alinity i tacrolimus result, unnecessary biopsy was performed on the patient.Additional information regarding the biopsy was requested; however, to date, it has not been provided and/or received.There was no further impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated alinity i tacrolimus result generated on the alinity i processing module for a patient.The result was released out of the lab.The following data was provided: patient 1: on (b)(6) 2024, sid (b)(6) , first result = 7.1 ng/ml.On (b)(6) 2024 ,sid (b)(6), second result = 12 ng/ml.The customer stated that due to the falsely elevated alinity i tacrolimus result, unnecessary biopsy was performed on the patient.Additional information regarding the biopsy was requested; however, to date, it has not been provided and/or received.There was no further impact to patient management reported.Update: on 07mar2024, the customer provided additional information.The sample was from a post kidney transplant patient and the blood draw was taken 24 hours after the medication was given.It was noted that both results were from the same blood draw.There was no further impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity i tacrolimus result 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.In addition, in-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates the reagent lot is performing as expected for this product.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot 56743fp00 and complaint issue.An accuracy testing was completed using an in-house retained reagent kit of lot 56743fp00 stored at the recommended storage condition.The testing meets all validity and acceptance criteria.A review of labeling was performed and found to sufficiently address the customer's issue.Based on the review of this issue, use error may have contributed to the customers issue as the complaint notes indicate the preprocessing (pipettes, tips, etc.) are quite old and added to technician inexperience, could have caused these discrepancies.Based on this investigation, no systemic issue or deficiency was identified for the alinity i tacrolimus reagent lot 56743fp00.
Additional Manufacturer Narrative
Section b5 - describe event or problem: this section was updated with additional information provided by the customer on 07mar2024.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
Update: on 07mar2024, the customer provided additional information.The sample was from a post kidney transplant patient and the blood draw was taken 24 hours after the medication was given.It was noted that both results were from the same blood draw.There was no further impact to patient management reported.

• Brand Name: ALINITY I TACROLIMUS REAGENT KIT
• Common Device Name: ENZYME IMMUNOASSAY, TRACROLIMUS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18817743
• Report Number: 1415939-2024-00010
• Device Sequence Number: 4289466
• Product Code: MLM
• UDI-Device Identifier: 00380740154516
• UDI-Public: (01)00380740154516(17)250128(10)56743FP00
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K070820
• 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,Followup
• Report Date (Section B): 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2025
• Device Catalogue Number: 09P42-20
• Device Lot Number: 56743FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 03/07/2024; 04/09/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/14/2024; 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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: ALNTY I PROCESSING MODU, 03R65-01, AI26103; ALNTY I PROCESSING MODU, 03R65-01, AI26103; ALNTY I PROCESSING MODU, 03R65-01, AI26103
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown