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	08/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of an elevated atellica im total hcg (thcg) result for one patient which was discordant relative to repeat testing when using thcg lot 356.An initial elevated atellica im thcg result was obtained for the patient in question.The sample was re-tested the same day, on the same analyzer and on an alternate atellica im system, and both repeat results were lower.The initial result was identified as falsely elevated.There are no allegations of patient harm or other adverse consequences in association with the observed discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im total hcg (thcg) result which was discordant relative to repeat testing.The interpretation of results section of the atellica im thcg 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 is investigating.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of observation of an elevated atellica im total hcg (thcg) result for one patient which was discordant relative to repeat testing.When the discordant sample was re-tested twice using the same analyzer on the same day, the repeat results were consistently lower.The lower results were considered correct.Quality control (qc) results were within expected ranges, and no issues were reported for any other patient samples.Review of instrument log data showed no evidence of any hardware issues affecting the delivery of assay reagents.Data for the affected sample show that more pressure was required to aspirate the initial discordant replicate than for the repeat tests, which did not demonstrate the same anomaly.The sample-aspiration pressure profile is consistent with the presence of micro-fibrin in the sample.On the basis of the available information, the cause for the discordant observation was a sample-quality issue.No product problem was identified.The customer is operational, and the reported issue is resolved by routine troubleshooting.Note: in section h6, codes for investigation findings and investigation conclusions have been updated.

• 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.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 20406914
• Report Number: 1219913-2024-00427
• Device Sequence Number: 11657545
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: (01)00630414600024(10)10027356(17)240915
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 10/22/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/22/2024
• 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 Sex: Unknown