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

Catalog Number 08P13-77

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

Section a1 patient identifier: sids =(b)(6).This report is being filed on an international product, alinity i stat high sensitive troponin-i, list number 08p13-77, that has a similar product distributed in the us, list number 04z21.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely decreased alinity i stat high sensitive troponin-i results on two patients.The controls were within range when the falsely decreased results were generated; however, during subsequent control runs, the controls values were out of range low.The customer stated that after the alinity i stat high sensitive troponin-i reagent have been on the analyzer for a couple of hours, the controls came back in range.The previously reported patient samples were repeated and higher results were obtained.The following data was provided: customer¿s reference range: =0.026 ng/ml.Sid (b)(6) initial result = 0.023 ng/ml; repeat result = 0.048 ng/ml.Sid (b)(6) initial result = 0.254 ng/ml; repeat result = 0.322 ng/ml.No impact to patient management was reported.

Event Description

The customer observed falsely decreased alinity i stat high sensitive troponin-i results on two patients.The controls were within range when the falsely decreased results were generated; however, during subsequent control runs, the controls values were out of range low.The customer stated that after the alinity i stat high sensitive troponin-i reagent have been on the analyzer for a couple of hours, the controls came back in range.The previously reported patient samples were repeated and higher results were obtained.The following data was provided: customer¿s reference range: =0.026 ng/ml sid (b)(6)initial result = 0.023 ng/ml; repeat result = 0.048 ng/ml sid (b)(6)initial result = 0.254 ng/ml; repeat result = 0.322 ng/ml no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely decreased alinity i stat high sensitive troponin-i results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, batch history record review, field data review, and labeling 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.Ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 51570ud01 and complaint issue.Batch history of the release testing was reviewed, and the values of controls and panels were well within their specification ranges.No downshift was identified for the complaint lot.The overall performance of the alinity i stat high sensitive troponin-i assay was reviewed using field data from customers worldwide.The median patient result for lot 51570ud01 is within the established limits and comparable with historical lots in the field.Labeling was reviewed and sufficiently addresses the customer's issue.Based on this investigation, no systemic issue or deficiency with the alinity i stat high sensitive troponin-i, reagent lot 51570ud01 was identified.The following sections have been corrected to reflect the current contact (b)(6): g1-contact office first name g1-contact office last name g1-contact office address 1 g1-contact office city g1-contact office postal code g1-contact office country g1-contact office phone number g1-contact office email g1-contact office fax number.

• Brand Name: ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
• Type of Device: 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: 17805392
• MDR Text Key: 324109872
• Report Number: 3005094123-2023-00255
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2023
• Device Catalogue Number: 08P13-77
• Device Lot Number: 51570UD01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/24/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)