MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI CALCITONIN (CAL); IMMULITE 2000 CALCITONIN (CAL)

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 08/15/2022

Event Type  malfunction  

Event Description

The customer observed discordant patient sample results when using immulite 2000 xpi calcitonin (cal) lot 325, in comparison to repeat results.Results for this sample were not reported to the physician.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant immulite 2000 xpi calcitonin (cal) results.

Manufacturer Narrative

A united states customer contacted the siemens customer care center (ccc) to report discordant immulite 2000 xpi calcitonin (cal) results when compared to repeat testing on the same instrument.It is unknown which result is correct (initial or repeat result).The limitations section of the instructions for use states the following: "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 continues to investigate.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00279 on 09-september-2022.Additional information 04-january-2023: siemens has reviewed a customer complaint regarding a discordant result of a patient sample with immulite 2000 calcitonin lot 325 from (b)(6) 2022.Additionally, the customer expressed concerns regarding the assay's accuracy and performance overtime.The initial result of this sample was 2.42 pmol/l, with repeat results at 1.62 pmol/l and 4.68 pmol/l.Siemens reviewed complaint database and did not find any complaints regarding the calcitonin assay from other customer sites.Siemens also reviewed kit release data of lot 325 and it met all manufacturer specifications for acceptance.Siemens then reviewed customer data from (b)(6) 2022 to (b)(6) 2022 and did not find any performance issues with the assay.The immulite 2000 calcitonin assay does not have a precision guideline or expectation for results below 3.36 pmol/l.Review of data indicates customer precision at the lower doses is within normal expectations for the calcitonin assay.There is no indication that siemens has a confirmed product issue with imprecision on the calcitonin assay.Siemens cannot rule out site specific factors as a contributing factor to the discordant result from (b)(6) 2022.Siemens has not identified a potential product issue.Customer is operational.The immulite 2000 calcitonin lot 325 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.Note: in section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: IMMULITE 2000 XPI CALCITONIN (CAL)
• Type of Device: IMMULITE 2000 CALCITONIN (CAL)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; gwynedd, llanberis ll55 4el ; UK
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis ll55 4el ; UK
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 15393421
• MDR Text Key: 303656177
• Report Number: 1219913-2022-00279
• Device Sequence Number: 1
• Product Code: JKR
• UDI-Device Identifier: 00630414961156
• UDI-Public: 00630414961156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 10381446
• Device Lot Number: 325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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