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	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 - patient identifier: complete sample id's are (b)(6).All available patient information was included.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated alinity i stat high sensitivity troponin-i and provided the following data for 1 patient: customer normal range is 0-52 ng/l sample id (b)(6) initial result was 71.7, which was questioned by patient¿s healthcare provider.Repeat result was <5, repeat result on another analyzer was <5.The customer reported that two samples were collected at the same time.Sample id (b)(6) initial result was <5, and repeat result was <5.The customer reported that they performed qc check after the reported event and there was no issue to report with the qc check.Customer stated they had a problem with the pre trigger level sensor and reported it has been replaced.There was no reported impact to patient management.
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 record review, and field data review.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.Device history review did not identify any non-conformances or deviations for the complaint lot.The ticket search by lot did not identify an increase in complaint activity.Review of ticket and trending did not identify any trends.In-house testing was conducted on lot 56521ud00, which determined that specifications were met, indicating acceptable lot performance.Labeling was reviewed and was found to address the customer reported issue.Based on the investigation, no systemic issue or deficiency was identified for the alinity i stat high sensitive troponin-i reagent, lot 56521ud00.
Event or Problem Description
The customer reported falsely elevated alinity i stat high sensitivity troponin-i and provided the following data for 1 patient: customer normal range is 0-52 ng/l sample id (b)(6) initial result was 71.7, which was questioned by patient¿s healthcare provider.Repeat result was <5, repeat result on another analyzer was <5.The customer reported that two samples were collected at the same time.Sample id (b)(6) initial result was <5, and repeat result was <5.The customer reported that they performed qc check after the reported event and there was no issue to report with the qc check.Customer stated they had a problem with the pre trigger level sensor and reported it has been replaced.There was no reported impact to patient management.

• 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: 18407581
• Report Number: 3005094123-2023-00387
• Device Sequence Number: 16817073
• Product Code: MMI
• UDI-Device Identifier: 00380740194079
• UDI-Public: 00380740194079
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/25/2024

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: 03/19/2024
• Device Catalogue Number: 04Z21-35
• Device Lot Number: 56521UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2023
• 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, AI20371; ALNTY I PROCESSING MODU, 03R65-01, AI20371
• Patient Sex: Unknown