MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT CYCLOSPORINE REAGENT KIT

Catalog Number 03R30-25

Device Problem Low Test Results (2458)

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

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

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 falsely decreased architect cyclosporine results on a patient diagnosed with aplastic anemia.Results provided: (b)(6) the physician is questioning the results from (b)(6) as the cyclosporine concentration target of 200 ng/ml is not being met.No impact to patient management was reported.

Manufacturer Narrative

Data and information provided by the customer was reviewed and supports the complaint issue without indication for any additional issue.The lot search review did not identify an increase in complaint activity for the issue of falsely decreased patient results.The ticket trending review for the likely cause list number did not identify a related trend for lot 24472fn00 and issue.No trends were identified.Manufacturing documentation for the likely cause did not identify any issues associated with the complaint issue.Labelling was reviewed which adequately addresses the current issue.Performance testing was completed using an in-house retained kit.All specifications were met indicating that the lot is performing acceptably.Based on our investigation, no systemic issue or product deficiency of the architect cyclosporine reagent lot 24472fn00 was identified.Section d4 lot# updated from unknown to 24472fn00.

• Brand Name: ARCHITECT CYCLOSPORINE REAGENT KIT
• Type of Device: CYCLOSPORINE
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12622723
• MDR Text Key: 276170883
• Report Number: 3008344661-2021-00183
• Device Sequence Number: 1
• Product Code: MKW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• 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: 11/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2021
• Device Catalogue Number: 03R30-25
• Device Lot Number: 24472FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, I1SR61759