MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300 ANALYZER

Model Number ATELLICA IM 1300 ANALYZER

Device Problem High Readings (2459)

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

Event Date 12/18/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted siemens to report that one falsely elevated troponin i (tnih) patient sample result was obtained on an atellica im 1300 analyzer.Siemens is investigating the event.

Event Description

One falsely elevated troponin i (tnih) patient sample result was obtained on an atellica im 1300 analyzer.The discordant result was reported to the physician.Approximately three hours later a second sample was collected from the same patient and tested on the same analyzer for troponin i.A lower troponin i result was obtained.The initial sample was repeated on the same analyzer and a lower result was obtained.The repeat result from the original sample was reported as the correct result.There are no known reports of patient intervention or adverse health consequences due to the event.

Manufacturer Narrative

The initial mdr 2432235-2022-00398 was submitted on 28-dec-2022.Additional information (30-dec-2023): a siemens customer service engineer (cse) was dispatched to the customer site to inspect the instrument.The cse observed a leak and removed and reattached a plunger because the retaining clip was not completely in position.The cse also adjusted the vertical position of the sample probe to the tip tray to correct a small gap when picking up sample tips.Siemens reviewed the available data, including analyzer log files, and found the leak in the sample probe, which was resolved by the cse, would not cause the reported falsely elevated troponin i result.Quality control (qc) materials recovered acceptably and no other samples around the same time period were impacted.Pre-analytical variables or sample specific issues may impact the quality of the sample and test results and are potential causes of the event.The cause of the falsely elevated troponin i (tnih) is unknown.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.Section h6 adverse event problem codes were updated.Corrected information: section d4.Catalog # was corrected from blank to 11066001.

• Brand Name: ATELLICA IM 1300 ANALYZER
• Type of Device: ATELLICA IM 1300 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 16062844
• MDR Text Key: 306593911
• Report Number: 2432235-2022-00398
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K151792
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA IM 1300 ANALYZER
• Device Catalogue Number: 11066001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female