MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT CYCLOSPORINE REAGENT KIT

Catalog Number 03R30-25

Device Problem High Test Results (2457)

Patient Problem Convulsion/Seizure (4406)

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported falsely elevated architect cyclosporine results on a (b)(6)patient.The results provided were: on (b)(6) 2021 sid (b)(6) initial = 812ng/ml / sample sent to another lab tested with the roche method on (b)(6) = 120ug/l / sample returned to original facility and on (b)(6) = 109.5ng/ml.The physician adjusted the cyclosporine dose based on the elevated result and then the child started having seizures.

Manufacturer Narrative

Component code: g01003.The complaint investigation for a potential false elevated architect cyclosporine result included a search for similar complaints, and review of the complaint text, instrument log data, trending data, labelling, and device history records.Return testing was not completed as returns were not available.Trending review determined no trends for falsely elevated results for the product.Performance of reagent lot 18202fn00 was evaluated using an in house retained kit of the lot.All specifications were met indicating the lot is performing acceptably.Device history record review of lot 18202fn00 did not show any potential non-conformances or deviations associated with the customers issue.Labelling was reviewed and found to adequately address the issue.The customer did not run qc as per package insert recommendation on the original sample test date.Per the quality control procedures section of the 3r30 package insert, the recommended control requirement for the architect cyclosporine assay is that a single sample of each control level be tested once every 24 hours each day of use.It was determined that this event was caused by use error, as the customer did not follow these recommendations.Furthermore, through their review, customer support concluded that an error in pre-treating the sample probably caused the elevated result.Based on the investigation, no systemic issue, malfunction, or deficiency of the architect cyclosporine assay, lot number 18202fn00 was identified.Update section d manufacturer site email to (b)(6).Update section g1 mfg site email to (b)(6).

• 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: 11544467
• MDR Text Key: 247025307
• Report Number: 3008344661-2021-00069
• 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,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Outcome(s): Disability
• Patient Age: 6 YR