MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 INTACT PTH; RADIOIMMUNOASSAY, PARATHYROID HORMONE

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	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states (ous) customer contacted a regional support center to report the observation of an 'increased incidence of low values' when using intact pth lot 387 on an immulite 2000 xpi instrument.The customer provided the results of eight patients compared to an alternate, non-siemens, method.The immulite 2000 xpi results were not reported to the physician(s).Quality control (qc) was within acceptable ranges at the time of testing.Clinical context is unknown and the reference range for the alternate method is unknown as well.The limitations section for the immulite 2000 intact pth instructions for use (ifu) states "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 an 'increased incidence of low values' when using intact pth lot 387 on an immulite 2000 xpi instrument.The customer provided the results of eight patients compared to an alternate, non-siemens, method.The immulite 2000 xpi results were not reported to the physician(s).Quality control (qc) was within acceptable ranges at the time of testing.Clinical context is unknown and the reference range for the alternate method is unknown as well.There are no known reports of patient intervention or adverse health consequences due to this issue.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2026-00016 on 13-jan-2025.Additional information 14-jan-2026.No patient results generated using intact pth kit lot 387 were reported to physician(s) and no testing was performed in an intraoperative scenario.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2026-00016 on 13-jan-2026.Siemens filed supplemental mdr 1219913-2026-00016-s1 on 28-jan-2026.Additional information 17-feb-2026: customers were notified via urgent medical device correction (umdc) imc25-05.C.Us and urgent field safety notice (ufsn) imc25-05.C.Ous-1 titled ¿intact pth potential negative bias with patient results¿ on 13-feb-2026.Customers were informed that the data initially provided for lot 387 is no longer representative of current performance and there is now a potential for falsely depressed intact pth patient results when using lots 387, 388 or 389.Based on testing native patient samples between 3 ¿ 92 pg/ml (0.3 ¿ 10 pmol/l), the average % bias was -28% with a range of individual biases from 0% to -72%.Customers were instructed to discontinue use of and discard kit lots 387, 388 and 389 and were informed there are no unaffected kit lots available.

• Brand Name: IMMULITE 2000 INTACT PTH
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• 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: jennifer cacace ; 333 coney street; east walpole, MA 02032 ; 8024302902
• MDR Report Key: 24055532
• Report Number: 1219913-2026-00016
• Device Sequence Number: 10023561
• Product Code: CEW
• UDI-Device Identifier: 00630414961910
• UDI-Public: (01)00630414961910(10)387(17)260720
• Combination Product (Y/N): N
• PMA/510(K) Number: K013566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026

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: 07/20/2026
• Device Model Number: N/A
• Device Catalogue Number: 10381441
• Device Lot Number: 387
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/17/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/28/2026; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1219913-09/24/2025-002-C
• Patient Sequence Number: 1
• Patient Sex: Unknown