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	07/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im total hcg (thcg) result with lot# 356 on a patient sample which was considered discordant relative to repeat testing.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.¿ siemens is evaluating this issue.
Event or Problem Description
The customer reports observation of an elevated atellica im total hcg (thcg) result with lot# 356 on a patient sample which was considered discordant relative to repeat testing.An initial elevated result was obtained for a 32-year-old female patient.This result was not reported to the physician(s).The same sample was retested on three different atellica im analyzers, which each time produced a significantly lower result (below assay measuring interval).The same sample was retested additionally on the original atellica im analyzer, and a result below assay measuring interval was obtained.The lower results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Mdr 1219913-2024-00393 was initially filed on 20-aug-2024.Additional information 28-aug-2024: siemens has concluded the investigation for the issue reported by a customer from outside the united states regarding an elevated atellica im total hcg (thcg) result with lot# 356 on a patient sample which was considered discordant relative to repeat testing.Siemens evaluated the instrument data and the information provided by the customer.The customer repeated other patient samples which were tested around the time of the discordance and no issue were found with other patient samples.It was noted by the customer that the discordant sample was presented with microfibrin.Preanalytic variables may affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.This problem was isolated to just one sample, there is no evidence of a reagent or instrument issue.The cause of the discordant result was consistent with a sample integrity issue, and the reported issue was resolved by routine troubleshooting.The customer is operational, and no further action is required.Note: in section h6, the 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.; registration #1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 20005283
• Report Number: 1219913-2024-00393
• Device Sequence Number: 20071918
• 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,Followup
• Report Date (Section B): 09/17/2024

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: 07/31/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 32 YR
• Patient Sex: Female