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

Catalog Number 03P25-27

Device Problem Low Test Results (2458)

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

Event Date 09/09/2023

Event Type  malfunction  

Event Description

The customer observed falsely depressed architect stat high sensitive troponin-i results generated for a 74-year-old male patient, who had chest pain on (b)(6) 2023.The patient has a history of heart failure, and current medication list includes stagid, eliquis, valsartan, and risperidone.The following data was provided ( customer¿s reference range for architect >5 pg/ml is positive.Customer¿s reference range for i-stat >30 pg/ml is positive): (b)(6) 2023 sample id (b)(6)initial results = <5 pg/ml, repeat result on i-stat = 170 pg/ml.(b)(6) 2023 same sample repeated on architect; result = 5-6 pg/ml, repeat on i-stat = 40 pg/ml.Same patient new sample obtained on (b)(6) 2023: sample id (b)(6) initial result = 6 pg/ml, repeat result on i-stat = 83 pg/ml.No impact to patient management was reported.

Manufacturer Narrative

This report is being filed on an international product, list number 3p25, that has a similar product distributed in the us, list number 2r98.An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 patient identification: sids (b)(6) and (b)(6) all available patient information was included.Additional patient details are not available.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the reagent lot performs as expected.Ticket trending review did not identify any trends.Device history record review did not identify any non-conformances, potential non-conformances, or deviations with the complaint lot.Customer field data was used to assess the performance of the architect stat high sensitive troponin-i assay using worldwide data.Review shows that the median patient result for lot 53407ud00 is within established limits and comparable with other lots in the field, confirming no systemic issue for the lot.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency with the architect stat high sensitive troponin-i reagent kit, lot number 53407ud00, was identified.

Event Description

The customer observed falsely depressed architect stat high sensitive troponin-i results generated for a 74-year-old male patient, who had chest pain on 09sep2023.The patient has a history of heart failure, and current medication list includes stagid, eliquis, valsartan, and risperidone.The following data was provided ( customer¿s reference range for architect >5 pg/ml is positive.Customer¿s reference range for i-stat >30 pg/ml is positive): 09sep2023 sample id (b)(6) initial results = <5 pg/ml, repeat result on i-stat = 170 pg/ml 10sep2023 same sample repeated on architect; result = 5-6 pg/ml, repeat on i-stat = 40 pg/ml (b)(6) initial result = 6 pg/ml, repeat result on i-stat = 83 pg/ml no impact to patient management was reported.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17857248
• MDR Text Key: 325088582
• Report Number: 3005094123-2023-00265
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 10/12/2023

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: 12/06/2023
• Device Catalogue Number: 03P25-27
• Device Lot Number: 53407UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR INTGR, 01L86-40, I1SR61096; ARC I1000SR INTGR, 01L86-40, I1SR61096
• Patient Age: 74 YR
• Patient Sex: Male