MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE

Catalog Number 01L75-25

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

The customer observed a falsely elevated cyclosporine result for one patient on the architect i1000sr analyzer.The following data was provided: initial 1300 ug/l (suspect falsely elevated, questioned by the doctor).1:4 dilution and obtained <800 ug/l with a cnrl flag, repeated the sample neat 1000 ug/l.1:4 dilution 50 ug/l (the dilution factor was not keyed in however), 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.(b)(4).An evaluation is in process.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling and accuracy testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The product was not available for return.Accuracy testing of the reagent lot with two levels of an internal panel (each level contains a known concentration of the cyclosporine analyte) met all specifications.Complaint information reasonably suggests the assay is performing as intended, and no malfunction of the device occurred.Based on the available information, no product deficiency was identified.

• Brand Name: ARCHITECT CYCLOSPORINE
• Type of Device: CYCLOSPORINE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 847937-512
• MDR Report Key: 3734577
• MDR Text Key: 4324575
• Report Number: 1415939-2014-00087
• Device Sequence Number: 1
• Product Code: MKW
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Type of Report: Initial,Followup
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2014
• Device Catalogue Number: 01L75-25
• Device Lot Number: 33387M500
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER; LN 01L86-01 SN (B)(4); ARCHITECT I1000SR ANALYZER; LN 01L86-01 SN (B)(4)