MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM TOTAL HCG (THCG) ASSAY; DHA 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	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 1219913-2024-00403 was initially filed on 13-sep-2024.Additional information (10-oct-2024): siemens healthcare diagnostics has concluded the investigation of the event.The customer obtained a falsely elevated discordant result on the atellica im total hcg (thcg) assay with reagent lot 356.On august 22, 2024, a patient sample resulted in 506.232 miu/ml when initially processed.The same sample was repeated the following day on another atellica im with a result of <2.0 miu/ml.The patient was also redrawn and resulted in <2.0 miu/ml.The lower repeat results were accepted as being correct.Quality control (qc) recovery was within acceptable ranges, and no issue was reported with other patient samples.No errors were found when reviewing the analyzer's error log.No signs of fibrin were visible when inspecting the sample.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.Review of the reagent trace file for the discordant sample showed no evidence of an aspiration or dispense issue.Review of the sample trace file showed several sample integrity pre-dispense too high flags.This flag does not cause integrity errors or impact the delivery of a sample but is a warning that should be addressed to ensure optimal performance.Autocheck data was reviewed and showed the secondary vacuum and wash probe vacuum were running at the upper end of the acceptable limit.Siemens recommended service actions for these observations, the system is performing acceptably, and the customer is operational.The reported issue is resolved by routine troubleshooting.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.
Additional Manufacturer Narrative
The customer reports observation of a discordant elevated total hcg (thcg) result for a patient sample on atellica im 1600 analyzer.The initial result was reported to the physician(s), who questioned the result.The interpretation of results section of the atellica im total hcg (thcg) instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens healthcare diagnostics is investigating.
Event or Problem Description
The customer reports observation of an elevated result for a 26-year-old female patient with the atellica im thcg lot 356.The initial result was reported to the physician(s) who questioned the result.The same sample was repeated on an alternate analyzer; the sample recovered less than the analytical measurement range vs.The initial result.The repeat result was reported to the physician(s) as a correct result.A corrected report was issued based on the repeat testing.There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: ATELLICA IM TOTAL HCG (THCG) ASSAY
• Common Device Name: DHA SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole; east walpole, MA 02032
• MDR Report Key: 20211948
• Report Number: 1219913-2024-00403
• Device Sequence Number: 20783806
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: (01)00630414600024(10)10027356(17)240915
• 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): N
• 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): 10/26/2024

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: 09/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 10027356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female