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

Model Number	02R9835
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The customer observed falsely elevated architect stat high sensitivity troponin-i results for several patients.The elevated results were still elevated after repeat testing and were questioned by physicians.There was no impact to patient management reported.
Additional Manufacturer Narrative
Additional concomitant product added to field d10.
Additional Manufacturer Narrative
The complaint investigation for a falsely elevated architect stat high sensitivity 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 29323ud00 was evaluated using worldwide data from abbottlink.Using the worldwide field data, reagent lot 29323ud00 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 on lot 29323ud00 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 sensitivity troponin-i, lot number 29323ud00, was identified.

• Brand Name: ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I REAGENT KIT
• Common Device Name: 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: 12823682
• Report Number: 3005094123-2021-00213
• Device Sequence Number: 6725869
• Product Code: MMI
• UDI-Device Identifier: 00380740175504
• UDI-Public: 00380740175504
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2021
• Device Model Number: 02R9835
• Device Catalogue Number: 02R98-35
• Device Lot Number: 29323UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 12/02/2021; 01/12/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/17/2021; 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, (B)(4).; ARC I2000SR INST, 03M74-02, (B)(4).; ARC I2000SR INST, 03M74-02,(B)(4).; ARC I2000SR INST, 03M74-02,(B)(4).; ARC I2000SR INST, 03M74-02,(B)(4).
• Patient Sex: Unknown