MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNLH); 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	10/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained an elevated atellica im troponin i (tnih) patient result (> than 99th%) for a 62-year-old male being treated for hypertension.The lot number in use has not been provided.The initial atellica im tnih result was reported to the physician and questioned.The sample was retested, and according to the customer, an identical result was obtained.The customer alleges the elevated results to be false positive.A corrected report was issued, but the correct/true result has not been provided.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 troponin i (tnih) patient result (> than 99th%) for a 62-year-old male being treated for hypertension.The customer alleges a false positive atellica im tnih result, but the correct result value has not been provided.The lot number in use has not been provided.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.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." this event is being reported as a conservative measure because of the limited information available.Siemens is investigating this event.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2025-00015 on 09-jan-2025.The reagent lot was not available at the time that this initial report was filed but is now available.Section d4 of this report has been amended with the lot information: lot number: 77106104.Expiration date: 26-jun-2025.Primary udi number: (b)(4).Section h4 of this report has been amended with the lot information: device manufacture date: 26-mar-2024.Siemens investigated an outside of the us customer report of elevated results for a 62-year-old male patient on atellica im high-sensitivity troponin i (tnih) lot 104.The sample was retested, and the result was similar to the initial result (> 99th% of 45 ng/l).Quality control (qc) was within the laboratory acceptable range.The customer alleges the elevated results to be false positive, however no other test results were provided to confirm a discordance.A correct result value was not provided.Return of the patient sample for further investigation was not pursued as the customer opted to perform interference testing at their site.Siemens requested information and recommended troubleshooting actions, but the customer has declined to provide any additional information regarding this event.Based on the limited information provided further evaluation is not possible.The cause of the discordant result cannot be determined and there is no evidence of a product issue.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 (TNLH)
• 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.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 21117950
• Report Number: 1219913-2025-00015
• Device Sequence Number: 15356164
• Product Code: MMI
• UDI-Device Identifier: 00630414006758
• UDI-Public: (01)00630414006758(10)77106104(17)250626
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171566
• 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): 03/28/2025

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: 06/26/2025
• Device Model Number: N/A
• Device Catalogue Number: 10997841
• Device Lot Number: 77106104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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: 62 YR
• Patient Sex: Male