MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number 08P13-34

Device Problem Low Test Results (2458)

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

Event Date 12/17/2022

Event Type  malfunction  

Event Description

The customer observed falsely decreased alinity i stat high sensitive troponin-i result on one patient.The following data was provided: on (b)(6) 2022, sid (b)(6).Result = < 4.0 ng/l.On (b)(6) 2022 sid (b)(6) repeat result = 4,187.1 ng/l.The customer¿s normal reference range is < 34 ng/l.It was noted that on (b)(6) 2022 the customer started getting error code 1196 (unable to perform the test, no signal spike) and error code 1403 (unable to perform the test, final read failure).No impact to patient management was reported.

Manufacturer Narrative

Patient identifier: complete sid is (b)(6).This report is being filed on an international product, alinity i stat high sensitive troponin-i, list number 08p13, 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.

Manufacturer Narrative

The complaint investigation for falsely decreased alinity i stat high sensitive troponin-i result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device 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.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 42430ud00 and complaint issue.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 42430ud00 is within established limits, indicating the reagent lot is comparable with other lots in the field, confirming no systemic issue for the lot.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 42430ud00 was identified.

• Brand Name: ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; 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: 16080565
• MDR Text Key: 307225743
• Report Number: 3005094123-2022-00310
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• 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: 02/06/2023

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: 12/30/2022
• Device Catalogue Number: 08P13-34
• Device Lot Number: 42430UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2022
• 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, AI01613; ALNTY I PROCESSING MODU, 03R65-01, AI01613