MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TOTAL HCG (THCG); HUMAN CHORIONIC GONADOTROPIN IMMUNOASSAY, PRODUCT CODE: JHI

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	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is investigating.The interpretation of results section of the instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the ifu states: "test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal nonpregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results - sometimes in consultation with other medical experts.This kit is not intended for any use other than assessment of pregnancy status.".
Event or Problem Description
A customer has reported a discordant, elevated result seen for one patient when using the atellica im total hcg (thcg) assay.This result was discordant relative to lower repeat-test results obtained using the same reagents on two instrument systems.The lower results were considered consistent with the patient's medical history and clinical picture.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant thcg results.
Additional Manufacturer Narrative
Mdr 1219913-2020-00589 was filed on 04-dec-2020 to report a discordant, elevated result seen for one patient when using the atellica im total hcg (thcg) assay.Additional information, 28-dec-2020: siemens has concluded the incident investigation.The customer reported a discordant patient result from the atellica im total hcg (thcg) assay, reagent lot 325.The initial result was 6.7 miu/ml and when repeated using the same reagents on two different instruments the results were 0.3 and 0.4 miu/ml.The sample was not respun before being repeated.The lower values were consistent with clinical expectation and therefore reported to the physician.Thcg quality control results from the date of initial testing were acceptable.System log files were requested but not provided for this issue.Siemens cannot definitively determine the cause of this discrepant result.Contributing factors such as sample integrity and/or preanalytical variable cannot be completely ruled out.The customer has monitored thcg performance and has no further concerns.Quality control results have been within in range and no issues were noted with other patient samples indicating that the instrument and reagents were performing acceptably.Based on the results of the investigation, return of the patient sample is not warranted.A potential product issue has not been identified.The customer is operational no further evaluation of the device is required.Note: in section h6, the investigation findings and investigation conclusion codes were added.

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• Common Device Name: HUMAN CHORIONIC GONADOTROPIN IMMUNOASSAY, PRODUCT CODE: JHI
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 10953210
• Report Number: 1219913-2020-00589
• Device Sequence Number: 3210904
• Product Code: JHI
• UDI-Device Identifier: 00630414600031
• UDI-Public: 00630414600031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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: 06/07/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995690
• Device Lot Number: 325
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR