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

Model Number IMMULITE 2000

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse replaced the sample probe and the dual resolution dilutor (drd).The cse performed precision testing, which was acceptable.The cause of the discordant, falsely low igf-1 results on multiple patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely low insulin-like growth factor 1 (igf-1) results were obtained on multiple 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, resulting higher.It is unknown if the corrected results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low igf-1 results.

Manufacturer Narrative

The initial mdr 2247117-2016-00004 was filed on january 08, 2016.Corrected information (02/01/2016): mdr 2247117-2016-00004 was filed with a date of 12/15/2015.The correct date is 12/04/2015.This has been corrected.

• 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: 5353626
• MDR Text Key: 35761839
• Report Number: 2247117-2016-00004
• Device Sequence Number: 1
• Product Code: DGC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K970227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• 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: 12/04/2015
• 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