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

Model Number IMMULITE 2000

Device Problem High Test Results (2457)

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

Event Date 01/21/2015

Event Type  malfunction  

Event Description

Discordant, falsely elevated progesterone (prg) and estradiol (e2) results were obtained on one patient sample on an immulite 2000 instrument.The discordant results were reported to the physician(s), who questioned them.The same sample was diluted 1:5 and tested for estradiol, also resulting high.The samples were repeated neat for progesterone and estradiol and at 1:5 dilution for estradiol on the same instrument, resulting lower than the initial results.Only the corrected result of progesterone was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated progesterone and estradiol results.

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.The cse performed a total service visit and replaced the sample and the reagent probe.The cse also replaced the substrate pump and the probe.The customer ran quality controls, which were within acceptable ranges.The cause of discordant, falsely elevated progesterone and estradiol results on one patient sample is unknown.The instrument is performing according to the specifications.No further evaluation of this devise is required.

• 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: 4530811
• MDR Text Key: 22059637
• Report Number: 2247117-2015-00004
• Device Sequence Number: 1
• Product Code: DGC
• Combination Product (y/n): N
• 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 Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• 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: 30002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2015
• 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