MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

A customer from outside the united states observed an atellica im high-sensitivity troponin i (tnih) result that was below the 99th%tile of 45.2 pg/ml (ng/l) for the atellica im tnih assay but the result was above the 99th%tile of 14 ng/l for troponin t from an alternate method.Siemens is investigating.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

The customer observed an atellica im high-sensitivity troponin i (tnih) result that was below the 99th%tile of 45.2 pg/ml (ng/l) for the atellica im tnih assay but the result was above the 99th%tile of 14 ng/l for troponin t from an alternate method.The result was reported to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the atellica im tnih result.

Manufacturer Narrative

Initial mdr 1219913-2021-00519 was reported on 23 dec 2021.Additional information received on 28 dec 2021: an outside us customer observed depressed atellica im tnih results on a patient sample vs alternate method results above the cutoff of 14 ng/l.Siemens reviewed the available information to determine probable cause and evaluate for potential product issue.Qc in range which indicates this is patient/sample specific incident.The escalation contains data from 22 patient samples run from (b)(6) 2019 to (b)(6) 2021.Samples were run on atellica im tnih and in some cases alternate method.One sample (patient 16) gave a atellica im tnih result < instructions for use (ifu) reference cutoff of 45 ng/l vs alternate method result >14 ng/l.The alternate method is a troponin t method vs the atellica im tnih which is a troponin i method; there is no claim that results will match between tests due to differences in antibodies/epitopes being measured.The limitations section of the ifu states: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.The atellica im tnih assay is designed to minimize interference from heterophilic antibodies." however patient samples may contain heterophilic antibodies and/or other interferences such as immune complexes (macro tni) that could react in immunoassays to give falsely elevated or depressed results.The interpretation of results section of the ifu states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." no potential product issue is observed.The customer is operational.No further action is needed.

• Brand Name: ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
• Type of Device: TROPONIN I
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 13080343
• MDR Text Key: 289337712
• Report Number: 1219913-2021-00519
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 00630414006703
• UDI-Public: 00630414006703
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K171566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

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 Model Number: N/A
• Device Catalogue Number: 10997840
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 12/28/2021
• Supplement Dates FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1