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

Model Number ATELLICA IM 1300

Device Problem Mechanical Jam (2983)

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

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

An outside the united states (ous) customer contacted siemens to report that the operator of an atellica im 1300 analyzer received a cut to a finger while removing a jammed reaction cuvette from the incubation bath ring of the analyzer.The analyzer had stopped and displayed an error message related to the cuvette pusher not receiving cuvettes.The operator inspected the analyzer and found a cuvette was jammed deep inside the incubation ring.The operator was using a tool to remove the cuvette and in the process injured the fingernail on the forefinger of the hand which started bleeding.The operator cleaned the wound and covered it with a bandage.After removing the cuvette the analyzer went back into ready mode, and the customer was able to process samples.The troubleshooting section of the atellica solution online help provides instructions for clearing an im cuvette jam.The cause of the cut to the finger was due to removing a jammed cuvette.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.

Event Description

The operator of an atellica im 1300 analyzer received a cut to a finger while removing a jammed reaction cuvette from the incubation bath ring of the analyzer.The cut was cleaned, and a bandage was applied.There are no known reports of patient intervention or adverse health consequences due to the event.

• 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 MANUFACTURING LTD.; registration #: 8020888; chapel lane; swords, co, dublin, 10040 ; EI 10040
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 15935981
• MDR Text Key: 308254247
• Report Number: 2432235-2022-00378
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: 00630414007960
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA IM 1300
• Device Catalogue Number: 11066001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2021
• 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 Sex: Female