MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300 ANALYZER

Model Number	ATELLICA IM 1300 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they obtained an erroneously elevated high-sensitivity troponin i (tnih) result on a patient sample on an atellica im 1300 analyzer.The initial result was reported to the physician(s) and was questioned.An hour later a new sample was drawn from the same patient and was processed on an alternate atellica im 1300 analyzer.The repeat result recovered lower than the initial result and was consistent with the patient¿s clinical history, considered correct.A corrected report was issued with the repat result.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated tnih result.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) and reported that they obtained an erroneously elevated high-sensitivity troponin i (tnih) result on a patient sample on an atellica im 1300 analyzer.Calibration and quality control (qc) recovered acceptably.Siemens review the information provided by the customer and the reagent issues were ruled out based on review of qc which showed recovery within acceptable ranges and no issues were reported with other patient samples.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit the cse inspected the analyzer, rinsed/washed acid and base reservoirs inspected and cleaned wash blocks.Based on the available information, the cause of the erroneously elevated tnih result could not be determined as the cse actions included replacement and servicing of multiple parts which was considered standard service actions.The customer is operational.A product issue was not identified.The instrument is performing according to specifications.No further evaluation is required.

• Brand Name: ATELLICA IM 1300 ANALYZER
• Common Device Name: ATELLICA IM 1300 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 2247117; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 25182148
• Report Number: 2432235-2026-00108
• Device Sequence Number: 21506044
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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 Model Number: ATELLICA IM 1300 ANALYZER
• Device Catalogue Number: 11066001
• Device Lot Number: N/A
• 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: 04/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown