MAUDE Adverse Event Report: Siemens Healthcare Diagnostics Products, Limited IMMULITE 2000 HCG; System, Test, Human Chorionic Gonadotropin

Model Number	N/A
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction

• Brand Name: IMMULITE 2000 HCG
• Common Device Name: System, Test, Human Chorionic Gonadotropin
• Manufacturer (Section D): Siemens Healthcare Diagnostics Products, Limited; glyn rhonwy, gwynedd; uk registration # 3002806944; llanberis ; UK
• Manufacturer (Section G): Siemens Healthcare Diagnostics Products, Limited; glyn rhonwy, gwynedd; uk registration #: 3002806944; llanberis ; UK
• Manufacturer Contact: jennifer cacace ; 333 coney street; east walpole, MA 02032 ; +1(802)430-2902
• MDR Report Key: 50785781
• Report Number: 2247117-2026-00012
• Device Sequence Number: 21475673
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: (01)00630414961132(10)485(17)260630
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K990222
• Number of Events Summarized: 1
• Summary Report (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): 09/17/2026

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 10381206
• Device Lot Number: 485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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