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

Model Number	1L77-25
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/25/2022
Type of Reportable Event	Serious Injury
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 observed falsely depressed architect tacrolimus results for one patient.The following data was provided: sid (b)(6), (b)(6) 2022 result 7.4 ng/ml, pharmacy increased dosage by 0.5 mg/day, patient redrawn on (b)(6) 2022 and resulted as 29.5 ng/ml (much higher than pharmacist would have expected with the dosage change) (lab's reference range: 4-12 ng/ml).Aside from medication dosage adjustment, no known impact to patient care was reported.
Additional Manufacturer Narrative
Additional information was received from the customer.The patient in question was an allogenic bone marrow transplant patient.The customer did not use a reference method that confirmed that the results were falsely elevated and was made aware of the situation after specimens had been discarded.The concern was for results that were inaccurate because after the pharmacist dosed the tacro for the results obtained on the first day, the next day the levels were extremely high and took multiple days to clear out/go down.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed.Return testing was not performed as returns were not available.Device history record review was performed on lot 45147fp00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends related to the falsely elevated patient results.Labeling was reviewed and found to adequately address the issue under review.Accuracy testing was performed on retained file kits of likely cause reagent lot 45147fp00, with internal tacrolimus panels in the same matrix as patient samples.Acceptance criteria were met, which indicates acceptable product performance.It was noted the patient had allogenic bone marrow transplant and was not using the architect tacrolimus assay per the intended use "as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy".Based on the investigation, no systemic issue or deficiency of the architect tacrolimus assay was identified.Corrected information for b5- the customer observed falsely elevated result (not falsely depressed) for one patient when using architect tacrolimus reagent lot 45147fp00.The initial result was result 7.4 ng/ml, patient was redrawn and resulted was 29.5 ng/ml (lab's reference range: 4-12 ng/ml).Corrected information for h6: a code updated from a090810 to a090809.

• Brand Name: ARCHITECT 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15960091
• Report Number: 1415939-2022-00088
• Device Sequence Number: 4912539
• Product Code: MLM
• UDI-Device Identifier: 00380740001377
• UDI-Public: 00380740001377
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2023

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: 02/28/2024
• Device Model Number: 1L77-25
• Device Catalogue Number: 01L77-25
• Device Lot Number: 45147FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 01/16/2023; 02/10/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 02/03/2023; 02/17/2023
• 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 I1000SR MOD, 01L86-01, I1SR54065; ARC I1000SR MOD, 01L86-01, I1SR54065; ARC I1000SR MOD, 01L86-01, I1SR54065
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown