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	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that an erroneously elevated high-sensitivity troponin i (tnih) result was obtained for one patient sample when processed on an atellica im 1300 analyzer.Quality control (qc) recovered within the laboratory established ranges prior to patient sample testing.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed a total service visit, tightened fitting found loose on aspirate probe 1, cleaned dirty ionizer fans, cleaned bottom of wash blocks, cleaned reagent probes, adjusted vacuum to within specification.The cse verified proper system function and qc, which recovered acceptably.Siemens further evaluated the event and determined that issues with the aspirate probe and wash blocks could result in residual fluid remaining in the cuvettes at the wash station, which may lead to elevated and/or spurious relative light unit (rlu) counts, potentially causing an elevated tnih result.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that an erroneously elevated high-sensitivity troponin i (tnih) result was obtained for one patient sample when processed on an atellica im 1300 analyzer (s/n: (b)(6).The initial elevated result was reported to the physician and was questioned.The same sample was reprocessed on an alternate atellica im analyzer and obtained a lower result.The lower result was considered correct since it matched the clinical history of the patient and was issued on the corrected report to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously 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: 22344153
• Report Number: 2432235-2025-00172
• Device Sequence Number: 14645499
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/27/2025

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: 06/03/2025
• Initial Report FDA Received Date: 06/27/2025
• 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