MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI FREE T3; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  malfunction  

Manufacturer Narrative

An outside united states (ous) customer contacted a siemens customer care center to report discordant free t3 results that were obtained on a patient samples on an immulite 2000 xpi instrument.It is unknown which result is correct.Quality controls (qcs) recovered within ranges and adjustment was valid on the day of the event.The customer has performed an instrument decontamination, transducer decontamination, water test, waste tube cleaning, and daily probe cleaning.The limitations section of the immulite 2000 free t3 instructions for use (ifu) states: "there may be some overlap between the euthyroid and hyperthyroid ranges." "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 Description

Discordant free t3 results were obtained on a patient sample on an immulite 2000 xpi instrument.The sample was repeated on the same immulite 2000 xpi instrument.The discordant results were not reported, as the customer is unsure which results are correct.There are no known reports of patient intervention or adverse health consequences due to the discordant free t3 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2023-00289 on 14-nov-2023.Additional information 07-mar-2024: siemens investigation has concluded.The customer stated they are seeing imprecision in the immulite 2000 free t3 assay with kit lot 103.Imprecision has been observed only in patients, especially in samples at the upper end of the reference range.The customer runs fresh serum samples.Siemens requested that the customer provide patient samples at the high end of the reference range for testing, but did not receive any samples from the customer.Immulite 2000 free t3 kit lot 103 expired on 31-dec-2023 so internal testing could not be performed to see if siemens could reproduce the customers observation.The customer no longer uses the immulite 2000 free t3 assay on the immulite 2000 and requires no further support on this complaint.Siemens has concluded the investigation and a product problem has not been identified.No further evaluation of the device is required.In section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: IMMULITE 2000 XPI FREE T3
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd LL554 EL; UK LL554EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd LL554 EL; UK LL554EL
• Manufacturer Contact: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 18133189
• MDR Text Key: 328072573
• Report Number: 1219913-2023-00289
• Device Sequence Number: 1
• Product Code: CDP
• UDI-Device Identifier: 00630414961361
• UDI-Public: 00630414961361
• Combination Product (y/n): N
• PMA/PMN Number: K974634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 10381675
• Device Lot Number: 103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1