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

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	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens filed the initial mdr 2247117-2025-00001 on 10-jan-2025.Additional information 28-feb-2025: siemens evaluated this issue and provided the following conclusion: siemens reviewed the error log that covered the date and time the discordant results were generated.The only error noted that could have contributed to discordant results was 'reagent temperature high'.Siemens was unable to identify this as the root cause due to the customer's decision to remove the instrument from service and decline troubleshooting support.The customer has decided to stop use of the immulite 2000 xpi serial number (b)(6).In section h6, the investigation findings and investigation conclusion codes were updated.
Additional Manufacturer Narrative
An outside the united states (ous) customer contacted a siemens remote support center to report a falsely depressed unconjugated estriol result obtained on an immulite 2000 xpi instrument.Quality control (qc) results were within range at 9:20 am and the discordant result was generated at 10:08 am.Qc was repeated at 11:39 am and the results were outside the expected ranges.Per the limitations section of the unconjugated estriol 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 unconjugated estriol result for one patient sample using kit lot 518 on an immulite 2000 xpi instrument.The erroneous result was reported to but not questioned by the physician(s).The sample was repeated on an alternate immulite 2000 xpi instrument and the repeat result, which was higher than the initial 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 unconjugated estriol result.

• Brand Name: IMMULITE 2000 XPI SYSTEM (IMMUNOASSAY ANALYZER)
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: jennifer cacace ; 511 benedict ave; tarrytown, NY 10591 ; 8024302902
• MDR Report Key: 21124190
• Report Number: 2247117-2025-00001
• Device Sequence Number: 12647017
• 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): 03/18/2025

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 Model Number: N/A
• Device Catalogue Number: 10373214
• Device Lot Number: N/A
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/18/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown