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	08/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states (ous) customer obtained an elevated patient result compared to a lower retest result using atellica im total hcg (thcg), lot 348.The interpretation of results section of the instructions for use states, "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings".Siemens investigated the event.There was no visible sign of fibrin in the sample.Maintenance was up to date and no related errors were observed in the event log.The atellica im thcg lot 348 calibration was within the manufacturer's acceptable limits.To troubleshoot this issue, the customer checked assay precision by running the level 1 control in replicates of 5.The %cv obtained was slightly higher than expected, so service was arranged.The siemens customer service engineer (cse) realigned the reagent probes and inspected the sample probe and the wash stations.These service actions are considered normal troubleshooting for issues of this nature.Atellica im thcg lot 348 precision was verified and found acceptable following the service visit.The customer is operational and no further troubleshooting is necessary.Based on the available, a product performance issue has not been identified.
Event or Problem Description
The customer observed discordance between initial and retest results with atellica im total hcg (thcg) on one patient sample.The initial result was elevated and had been reported to the physician but was not questioned.The retest result, obtained on a different instrument, was lower.A corrected report was issued with the lower result.There are no allegations of delay, patient or user intervention or adverse health consequences due to the discordant thcg result.

• 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.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 17741808
• Report Number: 1219913-2023-00191
• Device Sequence Number: 11798719
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: 00630414600024
• 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): Unknown
• 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): 09/13/2023

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: 10/07/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/13/2023
• Date Device Manufactured: 12/07/2022
• 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: 37 YR
• Patient Sex: Female