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 01/08/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse determined that the instrument had ongoing syringe errors.The cse replaced the syringe pump and the issue resolved.A siemens headquarters support center (hsc) specialist reviewed the service report and stated that the faulty syringe pump may have caused the discordant results due to the inaccurate dispense and aspiration volumes.Quality controls and patient samples have been running as expected after the troubleshooting was performed by the cse.The cause of the discordant progesterone results on two patient samples is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

Discordant progesterone results were obtained on two patient samples on an immulite instrument.The samples were repeated twice on the same instrument, resulting higher on the first repeat and lower on the second repeat run.All results were reported to the physician(s), who questioned them.The physician(s) accepted the higher progesterone results for both patients.There are no known reports of patient intervention or adverse health consequences due to the discordant progesterone results.

• Brand Name: IMMULITE
• Type of Device: IMMULITE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; flanders NJ 07836
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6298022
• MDR Text Key: 66450997
• Report Number: 2247117-2017-00011
• 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
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IMMULITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2017
• 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