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

Model Number	1L77-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
A journal article by bakir, ayfer; guney, mustafa, ¿paxlovid-tacrolimus drug¿drug interaction in a 23-year-old female kidney transplant patient with covid-19¿, clinical laboratory 68 (8-2022).Clinical laboratory publications.(aug 2022), documented false positive architect toxo igm results.The study noted that falsely elevated architect tacrolimus results occurred on a 23-yr old female kidney transplant patient who received paxlovid to treat a covid-19 infection.Results from the study provided: tacrolimus concentration was taken before first paxlovid tablet, after the morning dose of tacrolimus, and does not represent the trough concentration date (jan 2022) tacrolimus daily dose (mg) paxlovid dose (mg) tacrolimus concentration (ng/ml) recommended range for tacrolimus concentration in kidney transplant patients, up to 15 ng/ml baseline 4 8¿10 10 (admission day) 3 na 11 1 300 mg/100 mg × 1/day 10 tacrolimus was taken before 1st paxlovid dose, after the morning dose of tacrolimus, and does not represent the trough concentration 12 2 300 mg/100 mg × 2/day 13.6 13 2 48.5 14 1 92.4 15 0.5 85.8 16 (discharge) 0.5 62 17 0 na 18 0 14.9 na = not assessed no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for a falsely elevated architect tacrolimus result included a review of data and information from the article ¿paxlovid-tacrolimus drug¿drug interaction in a 23-year-old female kidney transplant patient with covid-19¿, trending review, labeling review, device history record, and in-house testing with a representative lot (since no lot number was provided).Trending review did not identify any trends for the issue for the product.Device history record review did not identify any related non-conformances or deviations with list number 01l77 and the complaint issue.Labeling was reviewed and found to adequately address the issue under review.In-house accuracy testing of a retained reagent kit was performed, showing that the reagent generates the expected results.All specifications were met.Based on the investigation, no systemic issue or deficiency of the architect tacrolimus assay was identified.
Event or Problem Description
A journal article by bakir, ayfer; guney, mustafa, ¿paxlovid-tacrolimus drug¿drug interaction in a 23-year-old female kidney transplant patient with covid-19¿, clinical laboratory 68 (8-2022).Clinical laboratory publications.(aug 2022), documented falsely elevated architect tacrolimus results.The study noted that falsely elevated architect tacrolimus results occurred on a 23-yr old female kidney transplant patient who received paxlovid to treat a covid-19 infection.Results from the study provided: tacrolimus concentration was taken before first paxlovid tablet, after the morning dose of tacrolimus, and does not represent the trough concentration date (jan 2022) tacrolimus daily dose (mg) paxlovid dose (mg) tacrolimus concentration (ng/ml) recommended range for tacrolimus concentration in kidney transplant patients, up to 15 ng/ml baseline 4 8¿10 10 (admission day) 3 na 11 1 300 mg/100 mg × 1/day 10 tacrolimus was taken before 1st paxlovid dose, after the morning dose of tacrolimus, and does not represent the trough concentration 12 2 300 mg/100 mg × 2/day 13.6 13 2 48.5 14 1 92.4 15 0.5 85.8 16 (discharge) 0.5 62 17 0 na 18 0 14.9 na = not assessed no impact to patient management was reported.

• 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: 15557766
• Report Number: 1415939-2022-00073
• Device Sequence Number: 5979568
• Product Code: MLM
• UDI-Device Identifier: 00380740001377
• UDI-Public: 00380740001377
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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
• Report Date (Section B): 10/25/2022

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 Model Number: 1L77-25
• Device Catalogue Number: 01L77-25
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 I2000SR INST, 03M74-02, 116UNKNOWN11; ARC I2000SR INST, 03M74-02, 116UNKNOWN11
• Patient Age: 23 YR
• Patient Sex: Female