MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE

Catalog Number 01L75-25

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been provided.

Event Description

The customer reported false decreased cyclosporine results when processing on the architect i2000sr.The following data was provided: the first patient result had an initial result of 101.10 and a retest result of 62.00.Another patient result (sid (b)(6)) had an initial result of 70.30 and retest result of 39.90.Units of measure were not provided.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of complaint text, a review of ticket trending, a review of device history, testing of a retained kit of the likely cause reagent lot, and a review of product labeling.Review of ticket trending and lot search did not identify an increase in complaint activity.No potential nonconformances, deviations, or nonconformances were identified.Testing of a retained kit indicated acceptable product performance.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: ARCHITECT CYCLOSPORINE
• Type of Device: CYCLOSPORINE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 8462709
• MDR Text Key: 145247857
• Report Number: 1415939-2019-00018
• Device Sequence Number: 1
• Product Code: MKW
• UDI-Device Identifier: 00380740001315
• UDI-Public: 00380740001315
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2019
• Device Catalogue Number: 01L75-25
• Device Lot Number: 93003M800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1