MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH); ATELLICA IM TNIH

Model Number 10997840

Device Problem Low Test Results (2458)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

Customer observed a depressed atellica im high-sensitivity troponin i (tnih) result for a patient sample compared to the other results from the same sample.There were no reports that treatment was altered or postponed or adverse health consequences due to the discordant depressed atellica im tnih result.

Manufacturer Narrative

An outside the us customer observed a depressed atellica im high-sensitivity troponin i (tnih) result from a sample that was considered discordant on comparison with the other results from the same sample.Interpretation of results of the instructions for use (ifu) states the following: " results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.

Manufacturer Narrative

The initial mdr 1219913-2022-00022 was filed on january 25, 2022.The initial mdr incorrectly referenced lot #550 and expiration date (october 1, 2022) in section d4.Section d4 of this report has been updated with the correct lot # 064 and expiration date as november 18, 2022.Additional information - march 09, 2022.An outside the us customer observed discordant results from atellica im high-sensitivity troponin i (tnih) assay with a sample from the patient compared to the repeat results on (b)(6), 2021.Siemens reviewed the available information to determine probable cause and evaluate for potential product issue.Initial and repeat results are > ifu 99th% cutoff of 45 ng/l.Sample handling and qc information is not available.A customer service engineer (cse) inspected sample probe, reagent probe and wash station.No issues were identified.A field service engineer (fse) performed preventive maintenance on this instrument on (b)(6), 2022.Auto check data was no longer available for the month of december.However, current auto check data looks healthy (lumo base check & wash / aspiration).Siemens cannot rule out a system issue and /or preanalytical issues as the cause.No potential product issue is observed.The customer is operational.No further action is required.Section d4 was updated.Section h4 was updated to add the date of manufacture as september 17, 2021.In section h6, investigation findings and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
• Type of Device: ATELLICA IM TNIH
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; walpole, MA 02032 ; 7372808688
• MDR Report Key: 13345128
• MDR Text Key: 291415523
• Report Number: 1219913-2022-00022
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 00630414006703
• UDI-Public: 00630414006703
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K171566
• 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: 04/05/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: 10997840
• Device Catalogue Number: 10997840
• Device Lot Number: 064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2021
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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