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 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens field service engineer (fse) was dispatched to the customer site.The fse evaluated the immulite 2000 xpi and the reagent pack on the system.The fse ran a comparison study using a new reagent lot that was sent to the customer, and the old reagent lot that produced the falsely low result.The results obtained on the samples when using the new reagent lot were satisfactory to the customer.The customer is going to use the new reagent lot going forward.The cause of the falsely low result on the one patient sample is unknown.The system is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer has obtained a falsely low result for the homocysteine assay on one patient sample on an immulite 2000 xpi instrument.The initial result on the patient sample was below the analytical measurement range.The sample was repeated on the same instrument and the result was higher and acceptable to the customer.The initial result was not reported to the physician(s).It is unknown if the repeat result was 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: 5477654
• MDR Text Key: 39649511
• Report Number: 2247117-2016-00013
• 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: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• 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: 02/19/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1