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

Model Number ATELLICA IM 1300 ANALYZER

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 12/24/2022

Event Type  malfunction  

Event Description

An operator allegedly hit her hand while attempting to remove jammed cuvettes from the incubating ring on an atellica im 1300 instrument.No further details were provided regarding the injury.The operator cleared the jammed cuvette by toggling the mechanics on the instrument on and off and removing the cuvette with needle nose pliers.The customer stated that there was no exposure to biohazardous material and no medical treatment or intervention required due to this event.There was no delay in processing patient samples.This mdr is being filed in an abundance of caution.There are no known reports of adverse health consequences due to this event.

Manufacturer Narrative

A united states customer contacted a siemens customer care center to report that cuvettes were jammed in the incubation ring on atellica im 1300 analyzer.An operator hit her hand while troubleshooting the jammed cuvettes.The operator ultimately cleared the cuvette from the incubation ring by emptying the ring, toggling the mechanics on the instrument on and off, and removing the stuck cuvette with a pair of needle nose pliers.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA IM 1300 ANALYZER
• Type of Device: ATELLICA IM 1300 ANALYZER
• 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 #: 2247117; flanders NJ 07836
• Manufacturer Contact: christina lam ; 511 benedict avenue; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 16150497
• MDR Text Key: 308751592
• Report Number: 2432235-2023-00004
• 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
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA IM 1300 ANALYZER
• Device Catalogue Number: 11066001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2022
• 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: 40 YR
• Patient Sex: Female