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

Catalog Number	04Z21-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final 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 a falsely elevated alinity i stat high sensitivity troponin-i result for a patient sample.The following data was provided: initial result = 0 pg/ml, repeat = 19 pg/ml, repeat on another analyzer = 0 pg/ml no impact to patient management was reported.
Event or Problem Description
The customer observed a falsely elevated alinity i stat high sensitivity troponin-i result for a patient sample.The following data was provided: initial result = 0 pg/ml, repeat = 19 pg/ml, repeat on another analyzer = 0 pg/ml no impact to patient management was reported.
Additional Manufacturer Narrative
Update: additional information in section d4 - expiration date updated from blank to 12/19/2023, and section h4 - device mfg date updated from blank to 7/10/2023.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 in house testing of a retained reagent kit lot 54072ud00.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends for the complaint lot/issue.Device history review did not identify any non-conformances or deviations with the complaint lot.In-house testing was completed using panels which mimic patient samples using an in-house retained kit.All specifications were met indicating that lot 54072ud00 is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i stat high sensitive troponin-i reagent lot 54072ud00 was identified.Corrected information in multiple sections of g1: contact office address 1, contact office city, contact office postal code, contact office email, contact office country, contact office first name, contact office last name, contact office phone number, contact office fax number.

• Brand Name: ALINITY I STAT HIGH SENSITIVITY TROPONIN-I
• Common Device Name: 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: 17814596
• Report Number: 3005094123-2023-00258
• Device Sequence Number: 17667598
• Product Code: MMI
• UDI-Device Identifier: 00380740194079
• UDI-Public: 00380740194079
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K202525
• 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): 11/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2023
• Device Catalogue Number: 04Z21-35
• Device Lot Number: 54072UD00
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Sex: Unknown