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	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated result with a patient sample with atellica im total hcg lot 338.The result was reported to the physician and the physician questioned the initial result.The sample was rerun on the atellica im and on an alternate platform.The repeat testing on the atellica im and the alternate platform yielded lower results.There are no known reports of patient intervention or adverse health consequences due to the discordant, total hcg, results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the customer care center (ccc) and reported a falsely elevated result with a patient sample with atellica im total hcg lot 338.The physician questioned the initial result, and the sample was rerun on the atellica im.The sample was also run on an alternate platform.The repeat result on the atellica im and the alternate platform yielded lower results.Qc was in range at the time of testing.The limitations section of the instructions for use (ifu) states the following: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present).There are many possible causes for these types of discordant results.Erroneous results may occur due to interference from identifiable serum constituents or patient-specific serum constituents." "if an aberrant or abnormal result, as defined by the laboratory protocol, occurs, laboratory personnel should first make certain that the system is performing and is operated and maintained in accordance with the product labeling.The user should then follow the laboratory protocol for advising the clinician of a result that appears to have deviated from the norms established by the laboratory.Test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal non-pregnant 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." siemens is investigating.
Additional Manufacturer Narrative
Initial mdr 1219913-2022-00186 was filed on 1-july-2022 additional information: 19-july- 2022.An outside of the united states (ous) customer contacted the customer care center (ccc) and reported an initial, falsely elevated, non-reproducible total hcg (thcg) result for a patient using the atellica im 1600.The initial result was 485.526 iu/l which was higher than expected and questioned by the physician.The same sample was repeated on atellica im with a result of 0.939 iu/l and on an alternate method with a result of 0.4 iu/l.Biorad immunoassay plus qc lot 85300 showed a slight negative bias but was in range at time of testing.No sample is available for further testing by siemens.Instrument sample and reagent trace files were requested for this investigation but were not received.Siemens cannot definitively determine the cause of this discrepant result.Contributing factors such as preanalytical variables and/or sample handling cannot be ruled out.Quality control was in range and no issues were noted with other patient samples, indicating that the instrument and reagents were performing acceptably.Repeat of the same sample yielded expected results.The customer continues to report results on the atellica im thcg assay without further concern.A potential product performance issue has not been identified.The customer is operational.No further action is needed.In section h6, investigation finding, and investigation conclusion codes were updated based on additional information.

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• Common Device Name: ATELLICA IM TOTAL HCG (THCG)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st; e. walpole, MA 02032 ; 7818564812
• MDR Report Key: 14885082
• Report Number: 1219913-2022-00186
• Device Sequence Number: 15023482
• Product Code: JHI
• UDI-Device Identifier: 00630414600031
• UDI-Public: 00630414600031
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: 09/12/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995690
• Device Lot Number: 338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2022
• 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 Sex: Female