MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM TOTAL HCG (THCG)

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of an elevated atellica im total hcg (thcg) result which was discordant relative to repeat testing when using lot 362.An initial elevated result was obtained for one (1) patient sample.The initial elevated result was reported to the physician who questioned the result.A new sample was drawn from the patient and tested on the original analyzer which obtained a lower result.The initial sample was retested on the original analyzer which also obtained a similar lower result.The lower result was considered correct and was issued on the corrected report to the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im total hcg (thcg) result which was discordant relative to repeat testing.Quality control (qc) recovered within the laboratory established ranges.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is evaluating the event.
Additional Manufacturer Narrative
Mdr 1219913-2025-00094 was initially filed on 09-may-2025.Additional information (13-may-2025): siemens concluded investigation for a customer complaint regarding observation of an elevated atellica im total hcg (thcg) result which was discordant relative to repeat testing.Siemens evaluated the instrument data, and the information provided by the customer.Reagent and instrument issues were ruled out based on qc recovery within acceptable ranges and no issues were reported with other patient samples.The sample and reagent merged trace files were reviewed which showed no evidence of hardware issues affecting thcg reagent delivery.The sample trace was within specification, but the pressure profile indicated a possible sample quality issue.Return of the patient sample for investigation is not warranted, as the discordant results were not reproducible.Based on the available information, the cause of the discordant result was consistent with preanalytical variables.The issue was resolved by routine troubleshooting; a product problem was not identified.The customer is operational, and no further actions are required.Note: in section h6, codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• Common Device Name: ATELLICA IM TOTAL HCG (THCG)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney st.; registration# 1219913; east walpole MA 02032
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21992460
• Report Number: 1219913-2025-00094
• Device Sequence Number: 4287716
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: (01)00630414600024(10)60171362(17)250906
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K192790
• 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): 06/09/2025

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 Expiration Date: 09/06/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 60171362
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female