MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

Model Number IMMULITE 2000

Device Problems Fire (1245); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center (ccc) and a customer service engineer (cse) was dispatched.Cse analyzed the instrument and found the digital fluidics circuit board, which is located next to the water and substrate pumps, malfunctioned.The potential cause of the digital fluidics circuit board malfunction was that the customer accidentally splashed fluid on the digital fluidics board during the cleaning procedure.Cse replaced the circuit board and performed a system and electrical safety check.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

Customer contacted siemens and stated that flame and smoke were observed near the dual resolution dilutor module (drd) from their immulite 2000 instrument while priming substrate.There were no patient samples affected and the fire department team was not called.Lab personnel had personal protection equipment (ppe) on at the time of the event.There are no known reports of operator and patient intervention or adverse health consequences due to the event.

Event Description

Customer contacted siemens and stated that flame and smoke were observed near the dual resolution dilutor module (drd) from their immulite 2000 instrument while priming substrate.Customer turned off the system and the smoke stopped.There were no patient samples affected.Lab personnel had personal protection equipment (ppe) on at the time of the event.There are no known reports of operator and patient intervention or adverse health consequences due to the event.

Manufacturer Narrative

Corrected information (19-nov-2019): brand name, model # was changed from "immulite 2000 xpi" instrument to "immulite 2000" instrument.Device code was changed from "1245 - fire" to "3265 - device handling problem" result code was changed from "180 - mechanical problem identified" to "114 - operational problem identified" the customer contacted siemens customer care center (ccc) and a customer service engineer (cse) was dispatched.Cse analyzed the instrument and found the digital fluidics circuit board, which is located next to the water and substrate pumps, malfunctioned.The potential cause of the digital fluidics circuit board malfunction was that the customer accidentally splashed fluid on the digital fluidics board during the substrate rinsing procedure.Cse replaced the circuit board and performed a system and electrical safety check.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: IMMULITE 2000
• Type of Device: IMMULITE 2000
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; flanders NJ 07836
• MDR Report Key: 9433183
• MDR Text Key: 169722290
• Report Number: 2247117-2019-00098
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: K970227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000
• Device Catalogue Number: 10380061
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1