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

Model Number	04Z2135
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
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.
Event or Problem Description
The customer observed a falsely elevated alinity i stat high sensitivity troponin-i result for a 60-year-old male with syncope/collapse, history of afib, hypertension, and type ii dm.The following data was provided: 4 draws on the same patient (results in ng/l): 1.Sid (b)(6), <4.2.Sid (b)(6), 73.351 (reported 4/23 4:20 pm), rerun is <4.3.Sid (b)(6), <4.4.Sid (b)(6), <4.Customer's reference range for male: >/=35, critical range >200).No impact to patient management was reported.
Additional 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 review, and in house testing of reagent lot 50575be00.Return testing was not completed as returns were not available.Data and information provided were reviewed and support the complaint issue without indication for any additional issue.Ticket search by lot indicates the reagent lot performs as expected.Ticket trending review did not identify any issues or trends.Device history record review did not identify any non-conformances or deviations associated with the complaint lot.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of the complaint lot.All specifications were met indicating that lot 50575ud00 is performing acceptably.Labeling was reviewed and found to adequately address the complaint issue.Based on the investigation, no systemic issue or deficiency of the alinity i stat high sensitivity troponin-i reagent lot 50575be00 was identified.
Event or Problem Description
The customer observed a falsely elevated alinity i stat high sensitivity troponin-i result for a 60-year-old male with syncope/collapse, history of afib, hypertension, and type ii dm.The following data was provided: 4 draws on the same patient (results in ng/l): 1.Sid (b)(6) <4 2.Sid (b)(6) 73.351 (reported 4/23 4:20 pm), rerun is <4.3.Sid (b)(6) <4 4.Sid (b)(6) <4 (customer's reference range for male: >/=35, critical range >200).No impact to patient management was reported.

• Brand Name: ALINITY I STAT HIGH SENSITIVITY TROPONON-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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16942579
• Report Number: 3005094123-2023-00131
• Device Sequence Number: 7012789
• Product Code: MMI
• UDI-Device Identifier: 00380740194079
• UDI-Public: 00380740194079
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/17/2023

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: 08/27/2023
• Device Model Number: 04Z2135
• Device Catalogue Number: 04Z21-35
• Device Lot Number: 50575UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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, AI24298; ALNTY I PROCESSING MODU, 03R65-01, AI24298
• Patient Age: 60 YR
• Patient Sex: Male