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	03/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a false positive architect stat high sensitive troponin-i result for a patient sample while running on the architect i2000 analyzer.The following data was provided: on (b)(6) 2022 sid (b)(6): initial troponin-i result: 116 ng/l (customer¿s cutoff > 35ng/l; repeat on another architect: 7.4 ng/l; re-centrifuged sample and repeated on original analyzer: 7.8 ng/ml there was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect stat high sensitive troponin-i results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.The ticket search by lot indicates that the reagent lot performs as expected for the product.Tracking and trending were reviewed and did not identify any related trends for the product for the issue.In-house testing was completed with a reagent kit of the complaint lot.All specifications were met indicating that the lot is performing acceptably.The device history record was reviewed and did not identify any non-conformances or deviations associated with the likely cause lot(s) and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect stat high sensitive troponin-i reagent lot 35249ud00 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 N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13906229
• Report Number: 3005094123-2022-00055
• Device Sequence Number: 4392180
• Product Code: MMI
• UDI-Device Identifier: 00380740175504
• UDI-Public: 00380740175504
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/21/2022

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: 05/30/2022
• Device Model Number: 02R9835
• Device Catalogue Number: 02R98-35
• Device Lot Number: 35249UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• 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)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown