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

Model Number IMMULITE 2000 XPI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens headquarters support center (hsc) reviewed the instrument files provided by the customer.There were no errors and nothing observed in the instrument files that indicated a malfunction in the instrument while the sample was being processed.A siemens field service engineer (fse) visited the customer site the day after the falsely low discordant was observed ((b)(6) 2016) and evaluated the instrument based on suggestions made by hsc.The issue with the system as per the fse was a earthing problem.There have been no other discordant results reported by the customer since the fse evaluated the instrument.The cause of the falsely low results was due to an earthing problem of the instrument.The system is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer obtained a falsely low result for the homocysteine assay on the immulite 2000 xpi, after switching to a new reagent lot 329.The sample was repeated again in duplicate and the results were acceptable to the customer.It is unknown if the initial or repeat results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely low result obtained on the immulite 2000 xpi instrument.

• Brand Name: IMMULITE 2000 XPI
• Type of Device: IMMULITE 2000 XPI
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 62 flanders bartley road; flanders NJ 07836
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 5541812
• MDR Text Key: 41683661
• Report Number: 2247117-2016-00019
• Device Sequence Number: 0
• Product Code: LPS
• Reporter Country Code: NL
• PMA/PMN Number: P010053/S007
• 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
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IMMULITE 2000 XPI
• Device Catalogue Number: 030001-3
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1