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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report a falsely depressed hcg result that was obtained on a patient sample on an immulite 2000 xpi instrument.Quality controls (qcs) recovered within ranges on the day of the event.A water test was performed on the immulite 2000 xpi instrument and passed.Per the limitations section in the immulite 2000 hcg instructions for use (ifu): "for diagnostic purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings." siemens is investigating.
Event or Problem Description
The customer reported the observation of a falsely depressed hcg result which was obtained on a patient sample on an immulite 2000 xpi instrument.The erroneous result was not reported to the physician(s).The sample was repeated on the same instrument the next day.The repeat result was higher than the erroneous result and the higher result matched the result from a reference instrument from another location.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed hcg result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2025-00118 on 19-jun-2025.Additional information 04-aug-2025: siemens healthineers evaluated the available information.The errorlog file was requested and not provided.The spy-files were reviewed and showed no evidence of foam or bubbles in the reagent, but the sample pipetting data indicated a possibility of bubbles or foam in the sample tube during the initial measurement.The customer is operational.The discordant result was observed with a single patient sample and it is suspected that the sample tube had bubbles or foam which caused the discordant initial result.The immulite 2000 hcg kit lot 483 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.In section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: IMMULITE 2000 HCG
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 22290005
• Report Number: 1219913-2025-00118
• Device Sequence Number: 8929743
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: (01)00630414961132(10)483(17)251114
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K990222
• 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): 08/11/2025

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: 11/14/2025
• Device Model Number: N/A
• Device Catalogue Number: 10381206
• Device Lot Number: 483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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