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	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely depressed total hcg (thcg) result was obtained on a patient sample on an atellica im 1600 analyzer.The erroneous result was not reported to the physician(s).The sample was then repeated on the initial atellica im 1600 analyzer after re-centrifugation.The repeat result was higher than the erroneous result.The higher result was considered correct.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed total hcg (thcg) result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report a falsely depressed total hcg (thcg) result was obtained on a patient sample on an atellica im 1600 analyzer.The erroneous result was not reported to the physician(s).The sample was then repeated on the initial atellica im 1600 analyzer after re-centrifugation.The repeat result was higher than the erroneous result.A corrected report was issued.The higher repeat result was believed to be correct.Biorad immunoassay plus qc lot 85330 resulted within range on the day of this event.Review of the thcg calibration data showed acceptable results.The maintenance of the analyzer was up to date.The error logs were analyzed, and no hardware issues occurred around the time of the discordant result.Based on available information, the cause of the discordant result is consistent with a sample integrity issue.Review of internal release data for atellica im thcg lot 348 shows acceptable performance.Siemens healthcare diagnostics is awaiting further information.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00257 on october 09, 2023.An outside united states (ous) customer contacted a siemens customer care center to report a falsely depressed total hcg (thcg) result was obtained on a patient sample on an atellica im 1600 analyzer.The erroneous result was not reported to the physician(s).The sample was then repeated on the initial atellica im 1600 analyzer after re-centrifugation.The repeat result was higher than the erroneous result.A corrected report was issued.October 19, 2023 additional information: the customer performed impact analysis and no other discordant results were identified.Based on available information, the cause of the discordant result is consistent with a sample integrity issue.Review of internal release data for the atellica im thcg lot 348 shows acceptable performance.No further evaluation of the device is required.In section h6, the investigation finding and investigation conclusion codes were 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: eiman sulieman ; 333 coney st.; east walpole, MA 02032 ; 7372808688
• MDR Report Key: 17899027
• Report Number: 1219913-2023-00257
• Device Sequence Number: 3366673
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: 00630414600024
• 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): 11/13/2023

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: 60167348
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/13/2023
• 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 Sex: Unknown