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

Model Number ATELLICA IM 1300

Device Problem Circuit Failure (1089)

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

Event Date 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer called a siemens customer care center (ccc) and reported that they obtained sample probe errors, noticed a burning smell, and observed a burnt component on an atellica im 1300 analyzer.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse replaced the pressure sensor primary control assembly (pca), printed circuit board (pcb), cleaned the air tubing, and inspected the sample probe plunger and tubing to ensure no clogs.Next, the cse reset the interlock bypass which restored power to the sample arm, turned mechanics on, and successfully homed the immunoassay module.Then, the cse performed a sample air pump calibration test and an autocheck, which were acceptable.After that, the cse entered run mode, loaded reagents, and processed all quality control (qc) successfully.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer reported that a sample probe of the atellica im 1300 analyzer halted.Upon further evaluation, the customer noticed that a burning smell emitted from the analyzer and observed a burnt component on the pressure sensor primary control assembly.The customer indicated that they did not observe flames.There was also no injury, impact to patient care, nor adverse health consequences due to the event.This report is being filed in an abundance of caution.

Manufacturer Narrative

Siemens filed initial mdr 2517506-2023-00142 on 26-apr-2023.Additional information (09-jun-2023): siemens further evaluated the malfunctioned printed circuit board (pcb) and determined that a capacitor malfunctioned.The purpose of this capacitor is to reduce noise and prevent voltage spikes.In this event, the capacitor potentially overheated or had a power surge.Once the capacitor malfunctioned, the software received an error and caused the sample probe to go offline and the instrument stopped processing samples, as designed.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA IM 1300
• Type of Device: ATELLICA IM 1300
• 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 number: 2247117; flanders NJ 07836
• Manufacturer Contact: douglas stanton ; 511 benedict ave; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 16820529
• MDR Text Key: 314082395
• Report Number: 2517506-2023-00142
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: 00630414007960
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151792
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA IM 1300
• Device Catalogue Number: 11066001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2023
• 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