MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1600 ANALYZER

Model Number	ATELLICA IM 1600 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) 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 the atellica im 1600 analyzer.Quality control (qc) was within range on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the wash station, aspirate probes, and wash 1 dispense.The cse observed that aspirate probe 4 was sticking on the vertical movement in and out of the wash ring and replaced the probe.Siemens reviewed instrument data and determined that the auto check data from this period was within acceptable limits, visual inspection of the discordant sample tube showed no signs of fibrin, review of the sample and reagent trace files for this sample showed no evidence of an aspiration or dispense issue.Siemens evaluated the event and determined that the cause of the falsely elevated thcg result cannot be determined.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that a falsely elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on the atellica im 1600 analyzer.The erroneous result was not reported to the physician(s).The sample was repeated on the original analyzer and on an alternate atellica ci 1900 analyzer.The repeat results recovered lower than the erroneous result and matched the patient¿s clinical history.The repeat result from the alternate analyzer was considered correct and reported to physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated thcg result.

• Brand Name: ATELLICA IM 1600 ANALYZER
• Common Device Name: ATELLICA IM 1600 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: 22894910
• Report Number: 2432235-2025-00223
• Device Sequence Number: 8851953
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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
• Report Date (Section B): 08/26/2025

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 1600 ANALYZER
• Device Catalogue Number: 11066000
• 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: 08/05/2025
• Initial Report FDA Received Date: 08/26/2025
• 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