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	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center and reported that falsely elevated high-sensitivity troponin i (tnih) results were obtained on 5 patient samples on an atellica im 1300 analyzer.Calibration and quality control (qc) were valid at the time of sample processing.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the analyzer, found significant fluid accumulation beneath wash ring, secondary vacuum pressure was high, suggesting blockage, cleaned vacuum tubing, cleaned vacuum pressure regulator, reset secondary vacuum pressure, replaced reagent 1 (r1) probe, ran auto check and qc, which recovered acceptably.The cause of the event is unknown.The analyzer 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 5 patient samples on an atellica im 1300 analyzer.The initial results were reported to the physician(s).The initial result of the sample identified as (b)(6) was questioned by the physician(s).The samples were repeated on an alternate atellica im 1300 analyzer.The repeat results recovered lower than the erroneous results.The repeat results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00102 on 04-apr-2025.Additional information (09-apr-2025): siemens evaluated the event and determined that undetected blockages may occur in the vacuum sub-system during normal operation; however, the analyzer will fail auto check for vacuum errors when the blockage is present.The evaluation also confirmed that when the vacuum errors generated, the analyzer will cancel all tests.Auto check will detect increases in vacuum pressure, regardless of where the occlusion occurs.Siemens further evaluated the event and concluded that the possible blockage in the secondary vacuum tubing potentially contributed to the falsely elevated high-sensitivity troponin i (tnih) results.The investigation conclusions code in section h6 was updated to reflect the additional information.The analyzer 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: 21773288
• Report Number: 2432235-2025-00102
• Device Sequence Number: 18556440
• 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): 04/15/2025

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: 03/14/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/15/2025
• 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