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 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed a false negative architect stat troponin-i result for one patient.The initial architect stat troponin-i result on (b)(6) 2021 was 1.72 ng/ml, auto retest auto validated as 0.01 ng/ml.The 0.01 ng/ml result was reported to physician.The sample was repeated, and the result was 1.72 ng/ml (true high/critical result).For investigation/troubleshooting purposes, the customer repeated the patient's sample with plasma (green top) and the results were high as well (no specific value provided).No adverse impact to patient management was reported.

Manufacturer Narrative

A ticket search for lot 30327un21 did not identify an increase complaint activity related to the falsely depressed patient results.A review of ticket trending data for the architect stat troponin-i (ln 2k41) was performed.Trending review did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with lot 30327un21 and the complaint issue.Historical performance of the lot 30327un21 was reviewed using worldwide field data.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 30327un21 are within the established limits.Therefore, no unusual reagent lot performance was identified for the lot 30327un21.Labeling was reviewed and found to adequately address the customer issue falsely depressed patient results.Based on the investigation, no systemic issue or deficiency of the architect stat troponin-i reagent lot 30327un21 was identified corrected data found in section d3 and section g1.

• 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 12639725
• MDR Text Key: 281922306
• Report Number: 1415939-2021-00041
• 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: 01/31/2022

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: 08/31/2022
• Device Model Number: 2K41-27
• Device Catalogue Number: 02K41-27
• Device Lot Number: 30327UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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, (B)(6); ARC I1000SR INTGR, 01L86-40, (B)(6)