MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300 ANALYZER

Model Number	ATELLICA IM 1300 ANALYZER
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a troponin (tnih) test was performed on a patient sample.The sample tested initially triggered an alarm stating "svc: signal error (signal shape error)".The alarm was not transmitted to the data management software (dms) and not sent to the dms for validation.It is still marked as "in progress" status in the dms on an atellica im 1300 analyzer.There was therefore a three-hour delay that was unapparent to the customer before the decision was made to dilute the sample and obtained tnih results to report.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center to report that a troponin (tnih) test was performed on an atellica im 1300 analyzer but not sent to the data management software (dms) for validation.The sample tested initially triggered an alarm stating "svc: signal error (signal shape error)" and did not produce a result when processed undiluted.This error did not appear in dms.The sample was marked as ¿in progress¿ in the dms.The customer manually diluted the sample and repeat testing was performed.A result was then obtained without error.Reagent related causes were ruled out based on review of the quality controls (qc) which showed recovery within acceptable ranges.The relative light units (rlu) of the undiluted result was 32839044.The s10 highest master curve standard (lot 113) rlu is 11682972.The diluted specimen lowered the rlu value sufficiently for the sample to read on curve and generate a result without the signal shape error.Siemens further evaluated the event and concluded the probable cause of the signal shape error is sample related based on the available information.According to the customer facing document, atellica solution operator¿s guide, signal shape errors are not transmitted to the laboratory information system (lis).The device performed within specifications during the event.The customer is operational.The complaint was resolved with routine troubleshooting.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2026-00095 on 17-apr-2026.Additional information (27-may-2026): siemens further investigated the delay in reporting a troponin test result and found that the sample was tested three times, without dilution, and in each case the analysis resulted in a test result of "error" and signal shape error flag.The result and flag were not transmitted to the data management system (dms).A delay in obtaining a result subsequently occurred.The same sample was repeated on the same atellica analyzer after making a manual 10x dilution, but the test result was above the analytical measurement range (amr) for troponin.The sample was additionally manually diluted 10x and then 5x.A very high troponin test result was obtained.Reagent issues were ruled out as a potential cause based on a review of quality control (qc) material that showed recovery within acceptable ranges and no issues were reported with other patient samples.Siemens reviewed the provided analyzer log file data and confirmed the atellica im 1300 analyzer performed per specification.The cause of the delay in reporting the troponin test result could not be determined based on the available information.The investigation conclusions code in section h6 was updated to reflect the additional information.No further evaluation of this analyzer is required.

• 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 MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: sumaiya rajpura ; 511 benedict ave.; tarrytown, NY 10591 ; 5513306538
• MDR Report Key: 24915602
• Report Number: 2432235-2026-00095
• Device Sequence Number: 9874385
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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: 03/26/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2019
• 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: 67 YR
• Patient Sex: Male