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

Model Number ATELLICA IM 1300

Device Problem Mechanical Jam (2983)

Patient Problem Laceration(s) (1946)

Event Date 02/04/2023

Event Type  malfunction  

Event Description

While troubleshooting a jammed cuvette on an atellica im 1300 analyzer, an operator hit her hand on a metal piece in the instrument above the ring loader area and cut her hand.The operator cleaned the wound and covered it with a band-aid.No further medical treatment was sought.There are no known reports of patient intervention or adverse health consequences due to the event.

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc) to report jammed cuvettes from the ring loader and wash ring motion errors on the atellica im 1300 analyzer.As per siemens request, an operator inspected the wash ring and cleared a jammed cuvette in the elevator latch.Then, the operator reported incubation ring errors.Next, the operator removed the ring loader, removed the jammed cuvettes, and replaced the ring loader.Subsequently, the wash ring and incubation ring were initiated and errors on the instrument were resolved.While troubleshooting, the operator sustained a cut to her hand.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse lubricated the elevator shaft.In a subsequent visit, the cse replaced the elevator and performed a successful auto check.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2023-00071 on 22-feb-2023.Additional information (02-mar-2023): siemens further investigated the event.The atellica solution online help does not instruct the operators to remove the incubation ring loader to clear cuvette jams.The customer removed the ring loader, removed additional cuvettes, and replaced the ring loader while troubleshooting.The instrument is performing according to specifications.No further evaluation of this device is required.The email address inputted under g1 contact office (and manufacturing site for devices) or compounding outsourcing facility was arbitrary inputted to comply with the character limit.The correct email address can be found in section b6.

• Brand Name: ATELLICA IM 1300
• Type of Device: ATELLICA IM 1300
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; 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: 16418738
• MDR Text Key: 310143191
• Report Number: 2432235-2023-00071
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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: 03/02/2023
• 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
• Patient Age: 30 YR
• Patient Sex: Female