MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE REAGENT KIT

Model Number 1L75-25

Device Problem Low Test Results (2458)

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

Event Date 07/13/2022

Event Type  malfunction  

Event Description

The customer observed a falsely decreased architect cyclosporine result for one patient.The following data was provided: initial result, after receiving medication on 11jul, was 872.5, repeat, on 13jul, was 4.3 ng/ml.There was no impact to patient management reported.

Manufacturer Narrative

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.Phone complete entry(b)(6).

Manufacturer Narrative

The complaint investigation for a falsely decreased architect cyclosporine result 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 testing of the complaint lot number.Trending review determined no related trend for the product.Return testing was not completed, as returns were not available.Accuracy testing was performed using an in-house retained kit of lot 37701fp00, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect cyclosporine reagent, lot number 37701fp00, was identified.

• Brand Name: ARCHITECT CYCLOSPORINE REAGENT KIT
• Type of Device: CYCLOSPORINE
• 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: 15099869
• MDR Text Key: 301095362
• Report Number: 1415939-2022-00055
• Device Sequence Number: 1
• Product Code: MKW
• UDI-Device Identifier: 00380740001315
• UDI-Public: 00380740001315
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080751
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Model Number: 1L75-25
• Device Catalogue Number: 01L75-25
• Device Lot Number: 37701FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)