MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE

Model Number IMMULITE

Device Problem Mechanical Problem (1384)

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

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

The cse was at the customer site to resolve "carousel temperature" errors which shut the system down.The cse checked the system and found voltage fluctuations.The cse installed a new power supply, verified all voltages, primed the system and ran a water test.The cse also replaced the diluter assembly.The customer ran quality controls, which resulted within acceptable range.The cause of smoke being emitted from the instrument is unknown.Siemens is investigating the issue.

Event Description

A siemens customer service engineer (cse) reported that smoke was emitted from an immulite instrument after performing troubleshooting on the system and installing new parts.The cse checked the system and found that wires were overheated.There are no reports of injuries, fire, burns or inhalation.There were no reports of adverse health consequences due to the smoke emitted from the instrument.

Manufacturer Narrative

The initial mdr 2247117-2016-00008 was filed on february 23, 2016.Additional information (01/26/2016): the overheated wires were found in the harness from the mother printed circuit board to the diluter assembly.The siemens customer service engineer (cse) replaced the harness to diluter and the mother printed circuit board.Siemens is investigating the issue.

Manufacturer Narrative

The initial mdr 2247117-2016-00008 was filed on february 23, 2016.Supplemental mdr 2247117-2016-00008_s1 was filed on february 23, 2016.Additional information (01/26/2016): the cause of smoke being emitted from the instrument was overheating of wire insulation.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: IMMULITE
• Type of Device: IMMULITE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 fladers bartley road; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; flanders NJ 07836
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5453121
• MDR Text Key: 39426733
• Report Number: 2247117-2016-00008
• Device Sequence Number: 1
• Product Code: JJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• 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