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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a depressed atellica im thcg result which was discordant relative to repeat testing.No issues were identified with quality control (qc) results or assay calibration at the time of the observation, and no instrument issues or errors were associated.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.
Event or Problem Description
The customer reports observation of a depressed atellica im total hcg (thcg) result for one patient which was discordant relative to repeat testing.Thcg reagent lot 352 was in use.An initial low thcg result was obtained for the affected patient.This result was not reported to the physician.The patient¿s serum sample was sent to another laboratory for repeat testing using the same method on another atellica im analyzer.Repeat testing produced reproducibly higher results, which were considered believable.An additional test was performed in another laboratory, confirming the higher results; this final result was accepted as correct.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 a depressed atellica im total hcg (thcg) result for one patient which was discordant relative to repeat testing.Repeat testing of the sample using the same method on two instruments produced consistently higher results; the initial low result was not reproduced.The instrument¿s system event log did not indicate any errors.It is noted that the same thcg reagent pack which had produced the discordant result was used over two days without any other discordant observations.Assay calibration and quality control (qc) results did not demonstrate any issues.Replicate testing of another sample, across multiple reagent packs and recalibrations, did not demonstrate any outlier results.On the basis of the observed qc results and the absence of issues with other samples, reagent problems were effectively ruled out.The issue was isolated to one sample and not reproducible.Based on the available information, the cause of the discordant result is consistent with a sample integrity issue.No systemic product problem was identified.The customer is operational, and no further action is required.

• 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: 18543345
• Report Number: 1219913-2024-00010
• Device Sequence Number: 7922944
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: 00630414600024
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/26/2024

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: 04/26/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 352
• 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: 01/16/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2023
• 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