MAUDE Adverse Event Report: ABBOTT IRELAND 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 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Was this device serviced by a third party? no.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 3r30 that has a similar product distributed in the us, list number 1l75.

Event Description

The customer reported a falsely elevated architect cyclosporine result for 1 patient.The following data was provided: on (b)(6) 2021, sid (b)(6) = result =113 ng/ml / on (b)(6) 2021, sid (b)(6) = result = 37.1 ng/ml.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false elevated architect cyclosporine results included a search for similar complaints, review of the complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Complaint activity review for lot 18202fn00 did not identify an increase in complaint activity for the issue of falsely elevated results.The tracking and trending review determined no trends were identified for the reagent lot associated with the issue.Performance of reagent lot 18202fn00 was evaluated using an in house retained kit of the complaint lot.All specifications were met indicating the lot is performing acceptably.Device history record review of lot 18202fn00 did not show any non-conformances or deviations associated with the issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect cyclosporine assay, lot number 18202fn00 was identified.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.Section d3 suspect medical device was updated including the mfg site email and fax number.Section g1 all manufacturers was updated including the mfg site email and mfg site fax number.

• Brand Name: ARCHITECT CYCLOSPORINE REAGENT KIT
• Type of Device: CYCLOSPORINE
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 11474964
• MDR Text Key: 278166969
• Report Number: 3008344661-2021-00061
• Device Sequence Number: 1
• Product Code: MKW
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2021
• Device Catalogue Number: 03R30-25
• Device Lot Number: 18202FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR51988; ARC I2K PROC MOD, 03M74-01, ISR51988