MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM TOTAL HCG (THCG) ASSAY; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

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	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer reported an observation of elevated total hcg (thcg) results on two patient samples when tested on an atellica im 1600 analyzer.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 patient's medical history, clinical presentation and other findings." siemens is investigating the event.
Event or Problem Description
The customer reports an observation of discordant (elevated) total hcg (thcg) results on two female patient samples when tested on an atellica im 1600 analyzer versus repeat testing.The initial discordant results were not reported to the physician(s).The same samples were retested on the alternate analyzers and lower results that fit each patient¿s medical history were obtained and considered correct reported.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Mdr (b)(4) was initially filed on 11-jun-2024.Additional information on 17-oct-2024: siemens healthcare diagnostics has concluded the investigation of the event.A customer from outside the united states reported an observation of elevated total hcg (thcg) results on two patient samples when tested on an atellica im 1600 analyzer.Siemens evaluated the instrument data and the information provided by the customer.The system showed instability of the vacuum subsystem around the time when the discordant result was generated.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse inspected the system and performed routine troubleshooting to resolve the vacuum issue.Following this routine troubleshooting intervention the precision was acceptable.The issue was resolved by routine troubleshooting.A product problem was not identified.The customer is operational and no further actions are required.In section h6, codes for investigation findings and investigation conclusions were updated.

• Brand Name: ATELLICA IM TOTAL HCG (THCG) ASSAY
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• 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: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 19511398
• Report Number: 1219913-2024-00349
• Device Sequence Number: 3456235
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: 00630414600024
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/07/2024

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: 09/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2023
• 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 Sex: Unknown