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

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	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained an elevated atellica im high sensitivity troponin i (tnih) patient sample result that was discordant relative to an alternate test method.The customer obtained an atellica im high sensitivity troponin i (tnih) patient sample result that was elevated (> than the assay reference range).The result was reported to the physician and the patient was subsequently sent to the hospital.The patient was retested at the hospital using an alternate method and the result was within the method's reference range.The patient also had a normal ecg, therefore the low/normal results were considered correct.As a result of the discordance, the customer performed retesting on the initial sample for troubleshooting and results remailed elevated.Calibration and quality control (qc) was acceptable at the time of all customer testing.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer obtained an elevated atellica im high sensitivity troponin i (tnih) patient sample result that was discordant relative to an alternate test method.The customer obtained an atellica im high sensitivity troponin i (tnih) patient sample result that was elevated (> than the assay reference range).The result was reported to the physician and the patient was subsequently sent to the hospital.The patient was retested at the hospital using an alternate method and the result was within the method's reference range.The patient also had a normal ecg, therefore the low/normal results were considered correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.As a result of the discordance, the customer performed retesting on the initial sample for troubleshooting and results remailed elevated.Calibration and quality control (qc) was acceptable at the time of all customer testing.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." siemens is investigating.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2025-00143 initial report on 15-jul-2025.Siemens completed investigation for an outside the united states (ous) customer complaint of an elevated atellica im high sensitivity troponin i (tnih) patient sample result that was discordant relative to an alternate test method.The customer obtained an atellica im high sensitivity troponin i (tnih) patient sample result that was elevated (> than the assay reference range).The result was reported to the physician, and the patient was subsequently sent to the hospital.The patient was retested at the hospital using an alternate method and the result was within the method's reference range.Patient ecg was normal.As part of customer troubleshooting, the customer performed retesting on the initial sample and treated the sample with heterophilic bocking tube (hbt) and non-specific binding tube (nabt) and the results were elevated and similar to the initial result.Reagent issues were ruled out based on review of quality control (qc) which showed recovery within acceptable ranges and no issues were reported with other patient samples.Return of the patient sample for further investigation is not warranted because the customer has conducted appropriate testing.Values obtained with different assay methods cannot be used interchangeably.The measured concentration of ctni in a given specimen can vary between assays due to differences in assay design and methodology.Based on the available information, the cause of the discordant result cannot be confirmed but appears to be a patient specific issue.The customer is operational, and the reported issue is resolved by routine troubleshooting.A product problem was not identified.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
• Common Device Name: 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.; registrations # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 22510802
• Report Number: 1219913-2025-00143
• Device Sequence Number: 9303968
• Product Code: MMI
• UDI-Device Identifier: 00630414006758
• UDI-Public: (01)00630414006758(10)90845110(17)260407
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K241165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 08/25/2025

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: 05/07/2026
• Device Model Number: N/A
• Device Catalogue Number: 10997841
• Device Lot Number: 90845110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/25/2025
• Date Device Manufactured: 01/07/2025
• 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: 49 YR
• Patient Sex: Male