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	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted siemens customer care center (ccc) and reported that falsely elevated high-sensitivity troponin i (tnih) results were obtained on four patient samples on an atellica im 1300 analyzer.The quality control (qc) was acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit the cse searched through error log and found the issue with wash station.Then, the cse performed an auto-check on wash station, and observed failed wash1 on lines, wash station 1 (ws1), wash station 2 (ws2), wash station 3 (ws3) and wash dispense (wd), observed flow of bubbles into wash stations from wash 1 lines, inspected wash 1 lines and identified that the gang fittings were not damaged and functioning properly.Later, the cse inspected bulk fluids drawer, caps on all fluids, wash1 cap, im cleaner cap and found that they were tightened and not loosed.The cse loosened caps and primed wash 1 fluids into wash ring and still observed some air bubbles, traced bubbles to bulkhead fitting connecting reservoir line to manifold.The cse swapped bulkhead fitting between reservoir and manifold for wash 1 to another fitting, primed wash 1 again, bubbles were flushed out and line was clear, primed im cleaner valve 2 with reagent probe priming, followed by priming reagent probes, checked secondary vacuum level, all caps on waste bottles and lines connecting to them, ran auto-check which passed.The cse ran quality control (qc) for tnih and it recovered out of range.The cse recalibrated tnih with new reagent pack (pack calibration) back within normal ranges, ran qc and precession which recovered acceptably.The cause of the event is unknown.The system is performing according to the specification.No further evaluation is required.
Event or Problem Description
The customer reported that falsely elevated high-sensitivity troponin i (tnih) results were obtained on four patient samples on an atellica im 1300 analyzer.The falsely elevated results were reported to the physician.The samples were reprocessed on an alternate atellica im 1300 analyzer and lower results were obtained which matched the patient¿s clinical history.The reprocessed results were considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated high-sensitivity troponin i (tnih) results.

• 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 #: 224711; 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: 21661743
• Report Number: 2432235-2025-00092
• Device Sequence Number: 12945938
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/21/2025

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: 02/25/2025
• Initial Report FDA Received Date: 03/21/2025
• 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