MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT STAT HIGH SENSITIVE TROPONIN-I; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number 03P25-26

Device Problem Low Test Results (2458)

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

Event Date 03/08/2023

Event Type  malfunction  

Event Description

The customer reported a falsely decreased architect stat high sensitive troponin-i result on a 71-yr old female patient.Results provided: sid (b)(6) result >50 ng/ml ((b)(6) 2023); sid (b)(6) result >50 ng/ml ((b)(6) 2023); sid (b)(6) result 41.46 ng/ml ((b)(6) 2023); sid (b)(6) result 28.33 ng/ml ((b)(6) 2023); sid (b)(6) result 0.02 ng/ml ((b)(6) 2023) ; repeat 19.08 ng/ml ((b)(6) 2023); sid (b)(6) result 11.30 ng/ml ((b)(6) 2023); sid (b)(6) result 8.09 ng/ml ((b)(6) 2023).Female diagnostic cutoff: 15.6 pg/ml.No impact to patient management was reported.

Manufacturer Narrative

A review of complaints determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Historical performance in the field of reagent lots using world-wide data through abbottlink was evaluated.The patient median result for lot 44262ud00was analyzed and found to be within established baselines and confirms no systemic issues for this lot.A review of the manufacturing documentation for the likely cause did not identify any issues associated with the customer¿s observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or product deficiency was identified for the architect stat high sensitive troponin-i, lot 44262ud00.This report is being filed on an international product, list number 3p25 that has a similar product distributed in the us, list number 2r98.

• Brand Name: ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16620067
• MDR Text Key: 312934409
• Report Number: 3005094123-2023-00076
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K191595
• 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
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 03P25-26
• Device Lot Number: 44262UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR RECONDIT KO, 03M74-65, ISR04620
• Patient Age: 71 YR
• Patient Sex: Female