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
Event or Problem Description
The customer reported the observation of elevated discordant patient results with androstenedione (and) kit lot 509 on an immulite® 2000 xpi immunoassay system.The results were reported to the physician(s), who questioned the results.The samples were reprocessed on an alternate immulite 2000 xpi instrument.The repeat results were reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2026-00044 on 20-feb-2026.A corrected supplemental report was filed on 04-march-2026.Additional information 27-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.The processing of these samples employed the same adjustment in effect, performed on january 21, 2026, at 3:57 am.The quality controls for the period were approved, with no record of qc rejections between january 23 and 24.Furthermore, no events were identified in the system logs that would justify the observed discrepancies.Three androstenedione assay reagent wedges were in use during the reported period between (b)(6) at 17:01 pm and (b)(6) at 23:50 pm.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 and quality control was in range at the time of testing.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 633 'clean dilution well fail-safe triggered', were observed.These errors cannot be ruled out as contributing to the discordant results.An instability or contamination of the androstenedione reagent wedges cannot be ruled out.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.
Additional Manufacturer Narrative
Mdr 1219913-2026-00044 was filed on february 20, 2026.Correction: after filing, it was noted on march 4, 2026 that the following information was missing from h11 of the initial report.An outside the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding the observation of elevated discordant patient results with androstenedione (and) reagent on an immulite® 2000 xpi immunoassay system.The adjustment was valid and quality control (qc) was within range on the date of testing.No events were identified in the system logs that would explain the observed discordant results the limitations section for the immulite 2000 androstenedione instructions for use states "for diagnostics 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.Section h8 was also updated to indicate initial use of device.

• Brand Name: IMMULITE 2000 ANDROSTENEDIONE
• Common Device Name: RADIOIMMUNOASSAY, ANDROSTENEDIONE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy, gwynedd; uk registration # 3002806944; llanberis LL554 EL; UK LL554EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy, gwynedd; uk registration # 3002806944; llanberis LL554 EL; UK LL554EL
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 24404659
• Report Number: 1219913-2026-00044
• Device Sequence Number: 13237847
• 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,Followup
• Report Date (Section B): 03/31/2026

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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 03/27/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/04/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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