MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT TROPONIN-I REAGENT KIT; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number 2K41-27

Device Problem Low Test Results (2458)

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

Event Date 03/02/2022

Event Type  malfunction  

Event Description

The customer observed a falsely depressed architect stat troponin-i result for one patient who was in the icu for nstemi non st segment myocardial infarction.The following data was provided (the customer¿s reference range is 0.0 to 0.07 ng/ml): sample 1: (b)(6) 2022 sid (b)(6) result on i1sr62473 (lot 86186un21) = 0.476 ng/ml, repeat = 0.592 ng/ml, repeat (with lot 81264un21) = 0.107 ng/ml repeats on i1sr52478 = 0.269 mg/ml and 0.289 ng/ml (lot 81264un21).Sample 2: (b)(6) 2022 sid (b)(6) result on i1sr52478 (lot 81264un21) = 0.039 ng/ml, repeat = 0.431 ng/ml, repeats on i1sr62473 = 0.500 ng/ml and 0.587 ng/ml.Sample 3: (b)(6) 2022 sid (b)(6) result on i1sr62473 (lot 88618un21) = 0.435 ng/ml, repeat = 0.445 ng/ml, repeat on i1sr52478 (lot 81264un21) = 0.056 ng/ml the customer is questioning the initial result generated from sample 2.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for falsely elevated architect stat high sensitive troponin-i results included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records, and field data review.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review on lot 81264un21 did not show any non-conformances or deviations associated with the complaint issue.The patient median data (divided into 3 groups) and cal f rlu mean were analyzed and compared to an established control limit.This evaluation indicated that all three levels of the patient medians and the cal f rlu mean for the lot 81264un21 are within the established limits.Therefore, no unusual reagent lot performance was identified for the lot 81264un21.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect stat high sensitive troponin-i for lot number 81264un21 was identified.

• Brand Name: ARCHITECT STAT TROPONIN-I REAGENT KIT
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13842965
• MDR Text Key: 297232050
• Report Number: 1415939-2022-00018
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: 00380740048525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

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: 11/20/2022
• Device Model Number: 2K41-27
• Device Catalogue Number: 02K41-27
• Device Lot Number: 81264UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR INTGR, 01L86-40, I1SR52478; ARC I1000SR INTGR, 01L86-40, I1SR52478