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

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding the observation of calibration and reproducibility issues on patient results with calcitonin (cal) on an immulite® 2000 xpi immunoassay system.Due to this issue, the customer is no longer processing patient samples with this assay.The instrument has been checked by a field service engineer (fse) who confirmed that it is operating correctly.Other assays are performing acceptably.Siemens is investigating the issue.As stated in the limitations section of the instructions for use: "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.".
Event or Problem Description
The customer reported the observation of calibration and reproducibility issues on patient results with calcitonin (cal), lot 340 on an immulite® 2000 xpi immunoassay system, serial number: (b)(6).The patient results provided to siemens were not reported to the physician as it is unknown which result is correct.There are no known reports of patient intervention or adverse health consequences due to the issue.
Additional Manufacturer Narrative
Mdr 1219913-2024-00473 was filed with fda on november 25, 2024.Correction - b3 - date of event was updated.December 16, 2024 - additional information.Siemens requested the following information from the customer to investigate the issue: maindatabase, spy file logs, error log files, sample type and sample handling.Was a full decontamination performed? the requested information was not provided.The limitations section of the instructions for use 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." the customer reports that no other assays have an issue.The system was checked by a field service engineer and confirmed that the instrument is operating correctly.

• Brand Name: IMMULITE 2000 CALCITONIN
• Common Device Name: RADIOIMMUNOASSAY, CALCITONIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED SIEMENS HEA; glyn rhonwy; registration #:3002806944; gwynedd llanberis LL55 4EL; UK LL55 4EL
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 20779070
• Report Number: 1219913-2024-00473
• Device Sequence Number: 5006127
• Product Code: JKR
• UDI-Device Identifier: 00630414961156
• UDI-Public: (01)00630414961156(10)340(17)250131
• Combination Product (Y/N): N
• Initial Reporter Country: BK
• PMA/510(K) Number: K023304
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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 Expiration Date: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 10381446
• Device Lot Number: 340
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/06/2025
• Date Device Manufactured: 03/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown