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	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that falsely elevated results with high-sensitivity troponin i (tnih) were obtained on two patient samples on an atellica im 1300 analyzer.The initial results were reported to the physician(s), who questioned the results.The samples were reprocessed on the alternate atellica im 1300 analyzer.The repeat results recovered within normal range and more closely matched the clinical picture.The repeat results were reported as the correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to falsely elevated tnih results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that falsely elevated high-sensitivity troponin i (tnih) results were obtained on two patient samples on an atellica im 1300 analyzer.Calibration and quality control (qc) were within acceptable ranges when erroneous results were obtained.The customer reran qc, which recovered out of range.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument, performed an auto check and found that the aspirate probes were not pulling vacuum, identified a clog in the secondary tubing, cleared tubing and ran auto check, which passed.Then, the cse ran qc.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00188 on 17-jul-2025.Additional information (17-jul-2025): post-service quality control (qc) recovered within the range.Siemens reviewed auto check data and found that the wash probe vacuum and wash probe baselines were elevated when compared to the secondary vacuum setpoint.This is an indication of an obstruction within the secondary or primary vacuum lines.Siemens further evaluated the event and determined that a clog within the fluidics system causing poor wash performance of the cuvette at the wash stations potentially contributed to the falsely elevated high-sensitivity troponin i (tnih) results.The investigation conclusions code in h6 was updated to reflect the additional information.The instrument 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: 22528592
• Report Number: 2432235-2025-00188
• Device Sequence Number: 7425583
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 08/05/2025

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: 06/23/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/05/2025
• 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