MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA); TROPONIN I IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im troponin i ultra (tni-ultra) result which was discordant relative to the patient's clinical picture.The elevated result was not reported to the physician, and additional testing was ordered.Repeat testing of a new sample the next day reproduced the initial result elevation.Additional testing using alternate methods, both locally and at three external laboratories, produced lower results which were accepted as correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.The limitations section of the product's instructions for use (ifu) states the following: "samples from patients receiving preparations of mouse monoclonal antibodies for therapy or diagnosis may contain human anti-mouse antibodies (hama).Such samples may show either falsely elevated or falsely depressed values when tested with this method." "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies." siemens is investigating.
Event or Problem Description
The customer reports observation of elevated atellica im troponin i ultra (tni-ultra) results which were discordant relative to the patient's clinical picture.The elevated results were not reported to the physician.Subsequent re-testing of the patient using alternate test methods produced lower results which were accepted as correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
Additional Manufacturer Narrative
Mdr 1219913-2022-00397 was initially filed on 2022-11-22.A customer from outside the united states reported observation of an elevated atellica im troponin i ultra (tni-ultra) result which was discordant relative to clinical indications and alternate-method testing.Quality control results for tni-ultra were within range at the time of the observation, indicating the possibility of a patient/sample-specific issue.There is no sample available for testing by siemens, preventing investigation for the presence of interfering substances.Results from different troponin determination methods cannot be used interchangeably due to differences in antibody sensitivity and specificity.According to the interpretation of results section of the assay's instructions for use (ifu), "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." based on the available information, no product performance issue has been identified.The customer is operational, and no additional investigation is required.Notes: in section h6, the codes for investigation findings and investigation conclusion have been updated.Mdr 1219913-2022-00396 was filed for the same event.

• Brand Name: ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA)
• Common Device Name: TROPONIN I IMMUNOASSAY
• 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: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 15846767
• Report Number: 1219913-2022-00397
• Device Sequence Number: 6525095
• Product Code: MMI
• UDI-Device Identifier: 00630414600109
• UDI-Public: 00630414600109
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995697
• Device Lot Number: 198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female