MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT STAT HIGH SENSITIVE TROPONIN-I; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number 03P25-37

Device Problem Low Test Results (2458)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 03p25, that has a similar product distributed in the us, list number 02r98.

Event Description

The customer observed a falsely decreased architect stat high sensitive troponin-i result for a (b)(6) patient.The following data was provided (customer¿s reference range is 0.0-34.2 ng/l): sample id (b)(6) initial result, on (b)(6) 2021, was 1.6, repeat was 44.1 ng/l.The sample was repeated on a cobas analyzer and the result was 61.90 pg/ml.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for a falsely elevated architect stat high sensitive troponin-i result included a review of complaint text, a search for similar complaints, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Historical performance of reagent lot 31412ud00 was evaluated using worldwide data from abbottlink.Using the worldwide field data, reagent lot 31412ud00 is performing similar to other reagent lots in the field confirming there was no systemic issue.Trending review determined no related trend for the issue for the product.Device history record review did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency for architect stat high sensitive troponin-i, lot number 31412ud00, was identified.Section g1 - contact office information updated.

• Brand Name: ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; 2246682940
• MDR Report Key: 13028672
• MDR Text Key: 285392490
• Report Number: 3005094123-2021-00248
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 02/10/2022

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: 02/19/2022
• Device Catalogue Number: 03P25-37
• Device Lot Number: 31412UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6); ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6)
• Patient Age: 79 YR