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	02/19/2025
Type of Reportable Event	Malfunction
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 range on the day of the event.The customer performed assay calibration and ran qc, which recovered acceptably.Siemens reviewed the instrument data and determined that there was no evidence of a hardware malfunction that impacted the delivery of tnih reagents or sample.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse performed auto check, observed secondary vacuum being high, adjusted the vacuum pressure, and observed excessive buildup at the sample tip eject.Then, the cse adjusted theta wedge alignment, performed a consecutive tip eject test without an error, inspected wash block and reagent probes, and determined that there were no issues, ran auto check again, which passed, reset the customer graphical user interface (gui), and ran qc, which recovered acceptably.The customer repeated all tnih samples processed on the original analyzer in the last 24 hours on an alternate analyzer, and the results matched the previously reported results.The cause of the falsely elevated tnih result is unknown.The analyzer is performing according to specifications.No further evaluation of this device is required.
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 questioned the result.The sample was repeated on the original analyzer and on an alternate atellica im 1300 analyzer.Also, a new sample drawn from the same patient was processed on the original analyzer and repeated on an alternate atellica im 1300 analyzer.The repeat results and redrawn sample results recovered lower than the erroneous result, matched the patient history, and were considered correct.The repeat result from the original analyzer was reported to the physician(s) as 'less than 3 ng/l.' there are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih result.

• 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 MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21523789
• Report Number: 2432235-2025-00075
• Device Sequence Number: 18569964
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 03/05/2025

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: 02/19/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2019
• 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