MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT CYCLOSPORINE REAGENT KIT

Catalog Number 03R30-25

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

H10: this report is being filed on an international product, list number 03r30-25 that has a similar product distributed in the us, list number 1l75.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated architect cyclosporine results which questioned by the physician on one patient.The results provided were: initial=640 ng/ml /redrawn and repeated after 5 hours=140 ng/ml there was no reported impact to patient management.

Manufacturer Narrative

The complaint evaluation 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 of architect cyclosporine reagent lot 47104fn00.The ticket search by lot indicates that the reagent lot(s) performs as expected for this product.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.Trending review determined no adverse trend for the issue for the product.Performance testing was performed using a retained kit of lot 47104fn00.And all specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Per product labelling values obtained with different assay methods cannot be used interchangeably due to differences in assay methods and cross reactivity with metabolites, nor should correction factors be applied.Therefore, consistent use of one assay for individual patients is recommended.When changing cyclosporine assay methods, including between abbott assays, in the course of monitoring a patient, additional sequential testing should be carried out to confirm baseline values.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect cyclosporine reagent lot 47104fn00.

Event Description

The customer observed falsely elevated architect cyclosporine results which questioned by the physician on one patient.The results provided were: initial=640 ng/ml /redrawn and repeated after 5 hours=140 ng/ml there was no reported impact to patient management.

• Brand Name: ARCHITECT CYCLOSPORINE REAGENT KIT
• Type of Device: CYCLOSPORINE
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17135173
• MDR Text Key: 317248046
• Report Number: 3008344661-2023-00110
• Device Sequence Number: 1
• Product Code: MKW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Catalogue Number: 03R30-25
• Device Lot Number: 47104FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6)