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	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely elevated high-sensitivity troponin i (tnih) result was obtained on a patient sample on an atellica im 1300 analyzer.The erroneous result was reported to the physician(s), who did not question the result.The sample was repeated on two alternate atellica im analyzers and on the original analyzer.The repeat results were lower than the erroneous result and matched the patient¿s historical result.The repeat results were considered correct, and the result of 18.93 ng/l was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely elevated high-sensitivity troponin i (tnih) result was obtained on a patient sample on an atellica im 1300 analyzer.Calibration was acceptable, and quality control (qc) was within the range on the day of the event.Siemens evaluated the event and ruled out reagent issues as qc recovered within acceptable ranges and no issues were reported with other patient samples.Siemens reviewed the instrument data and determined that there was no evidence of an issue impacting the delivery of tnih reagents or 100 l of sample.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse observed that secondary vacuum was low, readjusted it, and performed sample probe alignment.Next, the cse ran calibrator, qc, and then patient samples five times that had previously been processed on an alternate analyzer, all of which recovered acceptably.Siemens further evaluated the event and concluded that low vacuum, which affects the system fluidics and sample washing, potentially contributed to the falsely elevated tnih result.Extra fluid left in the cuvettes can cause elevated relative light units (rlus) and, therefore an elevated tnih result.The analyzer is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA IM 1300 ANALYZER
• Common Device Name: ATELLICA IM 1300 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; 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: 22911024
• Report Number: 2432235-2025-00225
• Device Sequence Number: 9110945
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 08/28/2025

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 Model Number: ATELLICA IM 1300 ANALYZER
• Device Catalogue Number: 11066001
• 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: 08/08/2025
• Initial Report FDA Received Date: 08/28/2025
• 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