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

Catalog Number 08P13-24

Device Problem Low Test Results (2458)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

The customer observed falsely decreased alinity i stat high sensitive troponin-i results on one patient who came from emergency room with chest pain complaint.The stunt inserted per ecg report.The results provided were: sid (b)(6) , initial=< 3.0 ng/l /repeated= < 3.0 ng/l.Redrawn after 3hrs and repeated sid (b)(6) = >50,000.0 ng/l.Laboratory reference range: female=<16 ng/l; male= <35 ng/l there was no reported impact to patient management.

Manufacturer Narrative

Complete information for section a patient information, 1.Patient identifier = sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, field data and accuracy testing for alinity i stat high sensitive troponin-i reagent lot 57638ud00.The ticket search determined that there is as expected complaint activity for the likely cause lot.A review of tracking and trending data did not identify any related trends for the product for the issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Historical performance of the alinity i stat high sensitive troponin-i reagents in the field was reviewed using data gathered via abbottlink from customers worldwide.The median value of the patient population for the complaint lot 57638ud00 is within the established limits and comparable to historical reagent lot performance.All field data demonstrating that the lot is performing as expected.Accuracy testing was performed for the complaint lot 57638ud00 using a retained kit with panels, which mimic patient samples, and all specifications were met indicating that the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i stat high sensitive troponin-i reagent lot 57638ud00.

Event Description

The customer observed falsely decreased alinity i stat high sensitive troponin-i results on one patient who came from emergency room with chest pain complaint.The stunt inserted per ecg report.The results provided were: sid (b)(6) initial=< 3.0 ng/l /repeated= < 3.0 ng/l redrawn after 3hrs and repeated (b)(6) 1975486= >50,000.0 ng/l laboratory reference range: female=<16 ng/l; male= <35 ng/l there was no reported impact to patient management.

• 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: 18810948
• MDR Text Key: 336618352
• Report Number: 3005094123-2024-00086
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 380740160630
• UDI-Public: (01)380740160630(17)240416(10)57638UD00
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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: 04/08/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2024
• Device Catalogue Number: 08P13-24
• Device Lot Number: 57638UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI25830.; ALNTY I PROCESSING MODU, 03R65-01, AI25830.