MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM; 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	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported out-of-range quality control (qc) results and an elevated atellica im total hcg (thcg) result was obtained for a patient sample on an atellica im 1300 analyzer.A siemens cse was dispatched to the customer¿s site.During the visit, the cse inspected the instrument and identified that the sample pump was failing.The pump was not replaced; however, some loose tubing on the sample probe manifold was resecured.Imprecision testing was performed, revealing highly variable results.The cse checked and adjusted the secondary pressure to specification, but the pressure would not stabilize.Further inspection revealed that the waste lines were clogged with debris.The vacuum was turned off, and the tubing was disassembled and cleaned.The secondary pressure regulator was cleaned and reset.After setting the secondary pressure, the full system auto check passed, the module was brought to a ready state, and qc was ordered.The qc values decreased but remained on the higher end.The customer then performed assay calibration, but qc was still out of range.Additional maintenance was performed, including cleaning the primary, secondary, and tertiary waste tubing, aspirate probes, wash block, and plunger tip, as well as replacing the pinch valve tubing.After these actions, the full system auto check passed, and qc was within acceptable range, though values were still elevated.Precision testing passed successfully.The instrument is performing according to specifications.Siemens is evaluating the cause of the event.
Event or Problem Description
The customer reported out-of-range quality control (qc) results and an elevated atellica im total hcg (thcg) result was obtained for a patient sample on an atellica im 1300 analyzer.The elevated result was reported to the physician(s), who did not question the result.Due to qc being out-of-ranges, the same sample was retested on the original atellica im analyzer which produced a significantly lower result.The lower result was considered correct, and a corrected report was issued to the physician(s) based on repeat testing.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Siemens filed an initial mdr 2432235-2025-00307 on 05-dec-2025.Additional information (09-dec-2025): siemens reviewed the instrument data, which showed multiple isolated spikes that caused test cancellations on the day of the event.The replacement and servicing of multiple parts mentioned in the initial report were standard service actions and the cause of the falsely elevated thcg result was unable to be determined.A product performance issue has not been identified.The instrument is performing according to specifications.No further evaluation of this device is required.Note: in section h6, the code for investigation conclusions has been updated.

• Brand Name: ATELLICA IM
• Common Device Name: ATELLICA IM 1300 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; 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: 23732449
• Report Number: 2432235-2025-00307
• Device Sequence Number: 21490724
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/27/2025

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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/27/2025
• 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 Age: 18 YR
• Patient Sex: Female