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	08/21/2025
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 total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an atellica im 1300 analyzer.Quality control (qc) and calibration were acceptable on the day of the event.Siemens reviewed the instrument data and identified no issues in the aspiration or dispense of thcg reagents with the 25ul of sample.Further reviewed the auto check data which was acceptable.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse reviewed the instrument, performed a total service visit (tsv), all manual and semi-auto alignments which include reagent probe alignments.Further the cse performed auto check, calibration and qc precision which passed acceptably.The cause of the event is unknown.The system was performing within specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported to siemens that an erroneously elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an atellica im 1300 analyzer.The erroneous result was reported to the physician(s) and was questioned.The sample was repeated on an original and two alternate atellica im analyzers.The repeat results recovered lower than the initial result and were considered correct.The repeat result of 0.6miu/ml was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated thcg 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 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: 23060928
• Report Number: 2432235-2025-00240
• Device Sequence Number: 9680776
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/16/2025

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: 08/21/2025
• Initial Report FDA Received Date: 09/16/2025
• 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