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	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely elevated alinity i stat high sensitivity troponin-i result for one female patient while running on the alinity i processing module.The qc was in range before and after the discrepant troponin result was generated.The following data was provided (customer's reference range for females is < 15 ng/l and critical high is > 50 ng/l): sid (b)(6): initial troponin result = 303 ng/l; repeat result on same sample next day = < 4 ng/l the customer stated 2 more samples from the patient were collected and tested after the initial sample and both samples generated < 4 ng/l results.There was no impact to patient management reported.
Additional Manufacturer Narrative
A1 - patient identifier: sid (b)(6).(complete sample id) all available patient information was 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 reported a falsely elevated alinity i stat high sensitivity troponin-i result for one female patient while running on the alinity i processing module.The qc was in range before and after the discrepant troponin result was generated.The following data was provided (customer's reference range for females is < 15 ng/l and critical high is > 50 ng/l): sid (b)(6): initial troponin result = 303 ng/l; repeat result on same sample next day = < 4 ng/l.The customer stated 2 more samples from the patient were collected and tested after the initial sample and both samples generated < 4 ng/l results.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity i stat high sensitivity troponin-i results included a search for similar complaints, and the review of complaint text, trending data, labeling, in-house testing, and device history records.Return testing was not performed 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 reagent lot performs as expected for this product.No increase in complaint activity identified.A review of ticket trending did not identify any related trends for the product for the issue.A review of the device history record did not identify any non-conformances or deviations associated with the reagent lot and complaint issue.Accuracy testing was completed using panels that mimic patient samples using an in-house retained kit of the complaint lot.All specifications were met indicating that lot 56521ud00 is performing acceptably.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was not identified for alinity i stat high sensitivity troponin-i, reagent lot 56521ud00.

• 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: 18688171
• Report Number: 3005094123-2024-00056
• Device Sequence Number: 7234089
• Product Code: MMI
• UDI-Device Identifier: 00380740194079
• UDI-Public: 00380740194079
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/21/2024

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: 01/25/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/21/2024
• 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, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Female