MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 XPI IMMUNOASSAY SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	IMMULITE 2000 XPI
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens customer care center to report discordant calcitonin (cal) results that were obtained on one patient sample using two different instruments of immulite 2000 xpi.A siemens customer service engineer went on site and performed the following: sample probe alignment, reagent probe alignment, drd alignment, priming verification of water and substrate pump dispensing, verification of tube lifter alignment, centrifuge speed adjustment, verification of vacuum pump aspiration, and verification of probe dispensing were performed.It was identified that the inside of the reagent probe was wet.It was found that the probe alignment in relation to the blind hole was incorrect, causing water to reach the washing station and wet the probe.The water balance connector had poor contact and was causing reading errors.This was repaired.The scale calibration, water filter replacement, and functional tests were performed, with acceptable results.Siemens continues to investigate.
Event or Problem Description
An outside of the united states (ous) customer contacted siemens customer care center to report discordant calcitonin (cal) results that were obtained on one patient sample using two different instruments of immulite 2000 xpi.The repeat testing was considered correct.The initial result was reported to physician.It is unknown if the physician questioned the result.There are no known reports of patient intervention or adverse health consequences due to this discordant results.

• Brand Name: IMMULITE 2000 XPI IMMUNOASSAY SYSTEM
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: bernd schick ; emil-von-behring- str. 76; marburg 35041 ; GM 35041 ; 91734802864
• MDR Report Key: 25111845
• Report Number: 2247117-2026-00004
• Device Sequence Number: 21419341
• Product Code: JJE
• UDI-Device Identifier: 00630414945422
• UDI-Public: (01)00630414945422
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K970227
• 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): 05/26/2026

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 Model Number: IMMULITE 2000 XPI
• Device Catalogue Number: 10373214
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female