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	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).Siemens investigated the ous customer report of an elevated atellica im total hcg (thcg) lot 356 result on a patient sample august 13, 2024, sample id# (b)(6)).The elevated result was reported and questioned.A new sample was drawn from the patient on a different day and retested on a different atellica im analyzer with the same lot (august 16, 2024, sample id# (b)(6)).The result was lower (below reference interval for non-pregnant females) and accepted as correct.The initial sample was retested on the same atellica im at a later date (august 27, 2024, sample id# (b)(6)) and resulted lower than the initial result, but greater than the reference interval for non-pregnant females.The sample had been stored frozen in the primary tube and was not re-centrifuged.Visual inspection of this sample showed fibrin.Quality control (qc) recovered within acceptable ranges and no issues were reported with other patient samples.The error log was evaluated, and no hardware errors were found during the processing of this sample.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." based on the available information, the cause of this discordant result is consistent with a sample integrity issue.There is no indication of a reagent or instrument issue.The customer is operational, and the reported issue was resolved by normal troubleshooting.
Event or Problem Description
The customer obtained an elevated atellica im total hcg (thcg) lot 356 result on a patient sample.This result was reported and questioned.A new sample was drawn from the patient on a different day and retested on a different atellica im analyzer with the same lot.The result was lower and accepted as correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.

• 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.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 20283519
• Report Number: 1219913-2024-00423
• Device Sequence Number: 20807544
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

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: 08/29/2024
• Initial Report FDA Received Date: 09/23/2024
• 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: Female