MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM TOTAL HCG (THCG) ASSAY

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	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a discordant elevated atellica im total hcg result for one patient.The initial result was reported to the physician, who did not question the result.The sample was remeasured on the same atellica im system and another atellica im system, and the results were lower.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant atellica im total hcg result.
Additional Manufacturer Narrative
The customer from united states obtained a discordant elevated atellica im total hcg result for one patient.The initial result was reported to the physician, who did not question the result.The sample was remeasured on the same atellica im system and another atellica im system, and the results were lower.The interpretation of results section of the atellica im total hcg 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 continues to investigate.
Additional Manufacturer Narrative
Initial mdr 1219913-2023-00037 was filed on feb 21, 2023 reporting the united states customer obtained a discordant elevated atellica im total hcg result for one patient.The initial result was reported to the physician, who did not question the result.The sample was remeasured on the same atellica im system and another atellica im system, and the results were lower.Additional information - mar 20, 2023 sample and reagent trace files were provided for sid# (b)(6) which resulted on (b)(6) 2023.Review of the reagent trace file did not show evidence of a hardware issue impacting delivery of the thcg reagents.The sample trace for sid#(b)(6) passed specification and did not show evidence of a sample probe issue impacting the sample aspiration/dispense.Additional information - mar 31, 2023 the customer reported falsely elevated non-reproducible patient results on atellica im total hcg (thcg) reagent lot 346.The sample was tested on (b)(6) 2023.The sample was initially high at 184.3 miu/ml and repeated significantly lower at 2.6 miu/ml.The lower repeat values were believed to be accurate.Nothing abnormal was noted with the appearance of the sample.Thcg reagent lot 346 calibration was valid and biorad qc lot 85320 resulted within range on both days of testing.Sample and reagent trace files were provided for the sample tested on (b)(6) 2023.Review of the reagent trace file did not show evidence of a hardware issue impacting delivery of the thcg reagents.The sample trace passed specification and did not show evidence of a probe issue impacting the sample aspiration and/or dispense.Service was also dispatched for this issue and a total service call was performed.The engineer replaced the wash ring ionizer but no other abnormalities were found.The customer continues to run thcg reagent lot 346 without any further concerns.Based on the available information, the cause of the discordant results is consistent with preanalytical variables and/or sample handling issues.No potential product issue is observed.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM TOTAL HCG (THCG) ASSAY
• Common Device Name: TOTAL HCG (THCG) ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 16410147
• Report Number: 1219913-2023-00037
• Device Sequence Number: 11594958
• Product Code: JHI
• UDI-Device Identifier: 00630414600031
• UDI-Public: 00630414600031
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: 07/13/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995690
• Device Lot Number: 346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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: Unknown