MAUDE Adverse Event Report: SIEMENS HEALTCHCARE DIAGNOSTICS INC IMMULITE 2000

Model Number IMMULITE 2000

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 12/05/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer.After evaluation of the instrument and instrument data, the cse performed a total service check.The cse discovered the sample probe tip was covered with gel like material, and replaced it.The cse ran a water test, precision testing with the two samples in question, and precision testing on quality controls, and results were within range.The cse and the technical applications specialist performed a 300 replicate precision testing on the estradiol method, which resulted with no outliers.The cause of the discordant progesterone and estradiol results was related to gel buildup on the sample probe tip.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant progesterone and estradiol results were obtained on two patient samples on an immulite 2000 instrument.The discordant results were reported to the physician(s), who questioned them.The samples were repeated on the same instrument, and the results matched the patients' clinical history.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant progesterone and estradiol results.

• Brand Name: IMMULITE 2000
• Type of Device: IMMULITE 2000
• Manufacturer (Section D): SIEMENS HEALTCHCARE DIAGNOSTICS INC; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5332727
• MDR Text Key: 34612478
• Report Number: 2247117-2015-00065
• Device Sequence Number: 0
• Product Code: JLX
• 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
• Type of Report: Initial
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• 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: 12/07/2015
• 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