MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE

Catalog Number 01L75-25

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

High test results.No consequences or impact to patient.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a falsely elevated cyclosporine result while using the architect cyclosporine assay.The customer provided the following data: (b)(6) 2015: initial 513, retest 120 ng/ml the specimen was retested again and it was indicated the result was similar to the first retest result.Specific data was not provided.The result was not reported from the laboratory.No impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, in-house testing, a search for similar complaints, and a review of labeling.Return material was not available from the customer.An accuracy testing protocol was executed; testing met the acceptance criteria and determined the reagent is performing acceptably.Tracking and trending did not identify an adverse trend for the lot in question.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency and no malfunction of the architect cyclosporine reagent, list 01l75, lot 43438m500, was 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: 4957057
• MDR Text Key: 23983843
• Report Number: 1415939-2015-00030
• Device Sequence Number: 1
• Product Code: MKW
• 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: Health Professional
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 01L75-25
• Device Lot Number: 43438M500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1