MAUDE Adverse Event Report: Siemens Healthcare Diagnostics Products, Limited IMMULITE 2000 HCG; 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	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the observation of discordant hcg results for one patient when using lot 485 on an immulite 2000 xpi instrument.Samples from four different dates were tested and on three of the dates, falsely elevated hcg results were reported to and questioned by the physician(s).Based on the three discordant hcg results, the customer 'focused on ectopic pregnancy'.The result from the fourth date was lower and agreed with testing from an alternate laboratory.In addition, ultrasound images showed no evidence of pregnancy.There are no known reports of patient intervention or adverse health consequences due to this issue.
Additional Manufacturer Narrative
An outside the united states (ous) customer contacted a siemens regional support center to report the observation of discordant hcg results for one patient when using lot 485 on an immulite 2000 xpi instrument.The results were reported to and questioned by the physician(s).The third sample was tested using a non-siemens method and the repeat result was lower than the result obtained on the immulite 2000 xpi.Based on the repeat result, and results from ultrasound images, a corrected report was issued.Siemens healthineers reviewed the complaint and provided the following investigation summary: a valid adjustment was in use and quality control (qc) results were within acceptable ranges on the dates of testing.Instrument files were analyzed and level sense data did not reveal any occurrence of foam or bubbles on the reagent.Sample carryover is unlikely as the results obtained from samples tested immediately prior were not undiluted samples with hcg values > 5000 miu/ml.The instrument files did show the discordant hcg results all used a specific reagent wedge and both the onboard stability and kit expiration date of the wedge had passed when it was used to generate the discordant results.Based on the available information, the probable cause of the discordant result is consistent with use of an expired reagent.A sample integrity issue or preanalytical variabilities cannot be ruled out as well.There is no evidence of a systemic reagent or instrument issue.The customer is operational performing hcg testing using a lot which has not expired.

• 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: 50785776
• Report Number: 2247117-2026-00011
• Device Sequence Number: 21475670
• 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