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

Model Number IMMULITE 2000

Device Problem Mechanical Problem (1384)

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

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse performed a total service check and reviewed the error log.The cse discovered errors for "two beads detected." the cse then verified the bead dispense positions and cleaned the bead drop tubing.The cse ran quality controls, which were within acceptable ranges.The customer stated that the discordant result on one patient sample was an isolated event.The customer did not obtain an additional discordant result.The cause of the discordant, falsely low estradiol result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely low estradiol (e2) result was obtained on one patient sample on an immulite 2000 instrument.The discordant result was not reported to the physician(s).The sample was also diluted with a dilution factor of 1:3 and was tested on the same instrument, resulting as expected.The sample was then repeated neat on the same instrument, resulting higher.The diluted result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low estradiol result.

• Brand Name: IMMULITE 2000
• Type of Device: IMMULITE 2000
• 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: 5094568
• MDR Text Key: 26487731
• Report Number: 2247117-2015-00050
• Device Sequence Number: 0
• Product Code: CHP
• Reporter Country Code: US
• PMA/PMN Number: K970227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2015
• 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