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	09/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im thcg result which was discordant relative to repeat testing.It was noted that quality control (qc) results were within acceptable ranges before and after the discordant observation.The customer ceased processing of thcg tests on the instrument which produced the discordant result.The instrument has demonstrated some recent history of thcg imprecision.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 an elevated atellica im total hcg (thcg) result which was discordant relative to repeat testing.An initial thcg result above the reference range for non-pregnant females was obtained for a 34-year-old female patient; this initial result was not reported to the physician.The sample was re-tested using another atellica im analyzer, and a lower result was produced.Multiple additional tests run on both instruments produced a series of similar lower results.The lower results were considered correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment in association with the observed discordance.
Additional Manufacturer Narrative
Mdr 1219913-2023-00188 was initially submitted on 2023-09-11.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.Multiple repeat tests using two atellica im instruments produced reproducibly lower results.No other results were identified as discordant.Remote monitoring of the system in question shows that the customer is currently reporting thcg results from this instrument, and that quality control (qc) results are within expected ranges, indicating no residual customer issue.Requested log files were not provided for review and investigation, so a specific cause could not be identified for the isolated elevated result for this patient.Further evaluation is not possible.On the basis of the available information, the customer is operational and no product problem was identified.

• 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
• MDR Report Key: 17721827
• Report Number: 1219913-2023-00188
• Device Sequence Number: 12553581
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: 00630414600024
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/28/2023

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: 10/07/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 348
• 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: 09/08/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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 Age: 34 YR
• Patient Sex: Female