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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

A customer reports observation of discordant elevated atellica im high-sensitivity troponin i (tnih) results for one patient sample which were discordant relative to alternate-method testing.An initial elevated atellica im tnih result was obtained.Per customer protocol, the same sample was re-tested in duplicate on the atellica im analyzer; similarly-elevated tnih results were obtained.The sample was also tested using an alternate-method test, which produced a much lower result.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.The customer has reported this observation of discordance retrospectively.Customers in australia are required to report discordant results to their competent authority (tga) and notify the manufacturer; this may be done retrospectively in a summary manner.The customer has declined to provide any additional information regarding patient diagnosis or treatment, and ultimate determinations regarding result indications.The customer also declined to provide any complaint materials and patient samples for siemens investigation.

Manufacturer Narrative

This incident occurred outside the united states.The customer has reported these observations of disagreement between methods retrospectively and not in a timely manner.The observations have been reported to siemens to comply with australian regulations (tga).Customers in australia are required to report discordant results to their competent authority (tga) and notify the manufacturer and this may be done retrospectively in a summary manner.The assay¿s instructions for use (ifu) states the following, under interpretation of results: ¿results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings.¿ it is noted that atellica im tnih is a high-sensitivity troponin i method whereas the alternate method is a point-of-care conventional-sensitivity troponin i method.Results from different methods are not interchangeable due to differences in assay specificity and sensitivity.The following is stated in the ifu, under limitations: ¿values obtained with different assay methods cannot be used interchangeably.Interpretations using serial measurements should be based on results obtained with the same assay method.The measured concentration of ctni in a given specimen can vary between assays due to differences in assay design and methodology.¿ there is no expectation that atellica im tnih and alternate troponin test methods will produce similar results.The customer has declined to provide any additional information regarding patient diagnosis or treatment, and ultimate determinations regarding result indications.The customer also declined to provide any complaint materials and patient samples for siemens investigation.Therefore, siemens is unable to further investigate this issue.

• Brand Name: ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 18803015
• MDR Text Key: 337623117
• Report Number: 1219913-2024-00048
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• 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: 10997841
• Device Lot Number: 090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Date Device Manufactured: 02/20/2023
• 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
• Patient Sex: Male