MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TOTAL HCG (THCG); 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	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation elevated atellica im total hcg (thcg) results which were discordant relative to repeat testing.No other discordance was identified.No issues were identified with quality control (qc) results or assay calibration at the time of the observation, and no instrument issues or errors were associated.The interpretation of results section of the atellica im thcg instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.
Event or Problem Description
The customer reports observation of elevated atellica im total hcg (thcg) results which were discordant relative to repeat testing when using thcg kit lot 352.Elevated thcg results (above assay cutoff for non-pregnant females) were obtained for three female patients.Repeat testing, using the same method other atellica im instruments, produced lower results.As the lower results were considered correct as they were reproducible and consistent with patient clinical presentation.There are no allegations of patient harm or other adverse consequences in association with the discordant results.
Additional Manufacturer Narrative
Mdr 1219913-2024-00262 was initially submitted on 2024-03-28.Siemens has concluded the investigation.A customer from outside the united states reported observation elevated atellica im total hcg (thcg) results which were discordant relative to repeat testing.Thcg quality control (qc) results were within expected ranges at the time of the discordant observations.Service was dispatched to inspect and perform routine instrument service, which included replacement of parts, adjustments, and realignments.Following this service interaction, thcg performance was verified by testing negative samples.Based on the available information, a specific cause for the initial elevated thcg results could not be determined.However, no product problem was identified.The customer is operational, and the observed issue is resolved following routine service actions.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• 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.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 10591 ; 5082985306
• MDR Report Key: 18991516
• Report Number: 1219913-2024-00262
• Device Sequence Number: 2946768
• 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): Unknown
• 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): 05/22/2024

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: 04/26/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Female