MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 ANDROSTENEDIONE; RADIOIMMUNOASSAY, ANDROSTENEDIONE

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	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report falsely elevated androstenedione results that were obtained on patient samples on an immulite 2000 xpi instrument.Quality controls (qcs) recovered within ranges on the day of the event (23-jan-2026), however it was noted that on the following day (b)(6) 2026) out of range qc results were observed.The qc results returned to recovering within ranges after the reagent pack was changed.The adjustment in use during this period was valid.No events were identified in the system event log that explain the discrepancy observed in the results.Per the limitations section of the immulite 2000 androstenedione 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 falsely elevated androstenedione results obtained on patient samples on an immulite 2000 xpi instrument.The erroneous results were reported to the physician(s), who questioned the results.The samples were repeated on an alternate immulite 2000 xpi instrument.The repeat results were reported, as the correct result, to the physician(s).Four samples were rectified (sids (b)(6).There are no known reports of patient intervention or adverse health consequences due to the discordant androstenedione results.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2026-00043 on 19-feb-2026.Additional information 23-mar-2026.Siemens evaluated this issue and provided the following conclusion: siemens healthineers reviewed the complaint for discordant androstenedione results when using lot 509 on an immulite 2000 xpi instrument.System files, including reagent level sense data, were reviewed for the time period the discordant results were generated.The encoder values did not reveal any occurrences of foam or bubbles on the reagent.The observation of discordant results began when a specific reagent wedge of androstenedione was put into use.Only this one wedge was used for the discordant patient results.An instability or contamination of this androstenedione reagent wedge cannot be ruled out.It is unclear if quality control was tested on this wedge of reagent.Quality control was run when the reagent wedge was replaced and was within acceptable ranges.The error log was reviewed for this same timeframe and an increase in the frequency of error 237, ¿sample pipettor did not level sense¿, and error 529 ¿tip jam¿ which indicate the sample pipettor did not sense liquid was noted.These errors cannot be ruled out as contributing to the discordant results.The customer is operational performing androstenedione testing after the reagent was replaced and calibrated.Immulite 2000 xpi androstenedione lot 509 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 conclusion codes were updated.

• Brand Name: IMMULITE 2000 ANDROSTENEDIONE
• Common Device Name: RADIOIMMUNOASSAY, ANDROSTENEDIONE
• 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: jennifer cacace ; 333 coney street; east walpole, MA 02032 ; 8024302902
• MDR Report Key: 24390173
• Report Number: 1219913-2026-00043
• Device Sequence Number: 10518930
• Product Code: CIZ
• UDI-Device Identifier: 00630414961026
• UDI-Public: (01)00630414961026(10)509(17)260718
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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): 03/24/2026

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: 07/18/2026
• Device Model Number: N/A
• Device Catalogue Number: 10381188
• Device Lot Number: 509
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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: Unknown