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	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an atellica im 1300 analyzer.The initial result was reported to the physician(s).The sample was reprocessed on an alternate atellica im analyzer.The repeat result was 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 thcg result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an atellica im 1300 analyzer.Calibration was acceptable and quality control (qc) was 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, ran auto check, found clog in vacuum line near the pressure regulator, removed clog and reset vacuum pressure.Then, the cse reviewed system message log which showed error in the dark counts signal, removed, cleaned and reinstalled lumo and photomultiplier tube (pmt), and restarted the analyzer.Next, the cse replaced lumo housing, performed alignments, replaced regulator and elevator, performed sample probe alignments, adjusted secondary vacuum pressure, ran full auto check, daily maintenance, qc and patient correlation, which passed.Siemens is evaluating the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2026-00001 on 05-jan-2026.Additional information (06-jan-2026): siemens reviewed the instrument data, and it indicated that there was a clog in the secondary vacuum pressure causing the wash probe vacuum to run high.Siemens further evaluated the event and determined that the occlusion in the vacuum tubing near the vacuum regulator potentially contributed to the falsely elevated total human chorionic gonadotropin (thcg) result.The device is performing according to specifications.No further evaluation is required.The investigation findings and investigation conclusions codes in h6 were updated to reflect the additional information.

• Brand Name: ATELLICA IM 1300 ANALYZER
• 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: 23955839
• Report Number: 2432235-2026-00001
• Device Sequence Number: 5611487
• 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): 01/23/2026

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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/23/2026
• 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: 30 YR
• Patient Sex: Female