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

Model Number	N/A
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2024-00319 on 17-may-2024.Additional information 19-jul-2024.Siemens evaluated this issue.Error logs and the main database were reviewed covering the time the imprecise results were generated.No sample level sensing, reagent level sensing or other errors that would have caused imprecise results were observed.Based on the available information the cause of the imprecise results is consistent with preanalytical variables.The customer is operational and the reported issue was resolved by routine troubleshooting.The immulite 2000 calcitonin assay, lot 336, 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
An outside the us (ous) customer contacted a siemens regional support center to report imprecise calcitonin results on two patient samples on an immulite 2000 xpi instrument.Siemens is investigating.
Event or Problem Description
The customer reported imprecise calcitonin results were obtained on two patient samples on an immulite xpi instrument.The samples were repeated on the same analyzer and on an alternate immulite 2000 xpi and the true result of both samples was determined to be 10.5 pg/ml.There are no known reports of patient intervention or adverse health consequences due to the imprecise calcitonin results.

• Brand Name: IMMULITE 2000 CALCITONIN
• Common Device Name: RADIOIMMUNOASSAY, CALCITONIN
• 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 st.; east walpole, MA 02032 ; 8024302902
• MDR Report Key: 19341873
• Report Number: 1219913-2024-00319
• Device Sequence Number: 12545409
• Product Code: JKR
• UDI-Device Identifier: 00630414961156
• UDI-Public: 00630414961156
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K023304
• 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): 07/24/2024

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: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 10381446
• Device Lot Number: 336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• 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