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	10/24/2025
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 erroneous result was not reported to the physician(s).The sample was repeated on the original analyzer, and a similar elevated result was obtained.Then, the sample was repeated twice on an alternate analyzer, and lower results were obtained, which were considered correct.The repeat result of 660 pg/ml was reported to the physician(s).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) regarding an erroneously elevated high-sensitivity troponin i (tnih) result obtained on a patient sample on an atellica im 1300 analyzer.Calibration recovered acceptably.Quality control (qc) recovered within the lab ranges before the erroneous results but recovered outside the lab ranges when run after the erroneous results.A siemens customer service engineer (cse) was dispatched to customer¿s site.During the visit, the cse inspected the analyzer and found sample probe integrity errors, checked acid and base dispense and reagent probe dispenses, which were acceptable.Then, the cse removed pack and checked alignment, which was good.Next, the cse removed wash manifolds, cleaned and replaced it, ran sample pump calibration and ran auto check, which passed.Then, the cse ran a calibration, which failed due to sample aspirate errors, replaced sample pump, reinstalled old sample pump, attempted to stylette sample tip plunger.Further, the cse replaced the sample probe plunger and performed all sample probe alignments (theta wedge, manual outer ring center and vertical, sample tip tray locations and vertical, vessel mover module (vmm) alignment, and sample probe air pump calibration), ran daily auto check, maintenance, calibration and qc, which were acceptable.Siemens has evaluated the event and determined that the cause of the erroneously elevated tnih result is unknown.The instrument is performing according to the 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: 23567710
• Report Number: 2432235-2025-00293
• Device Sequence Number: 10120647
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/17/2025

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: 10/24/2025
• Initial Report FDA Received Date: 11/17/2025
• 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