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 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens field service engineer (fse) was not sent to the customer site as the customer indicated that they could not rule out the presence of an air bubble in the sample when initially tested on the immulite 2000 xpi.The customer continues to run the immulite 2000 xpi, and have advised all their laboratory technicians to double check sample and reagent for air bubbles prior to use.The cause of the falsely low homocysteine 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

A discordant, falsely low homocysteine result was obtained on one patient sample on an immulite 2000 xpi instrument.The discordant result was not reported to the physician(s).The sample was repeated on the same instrument resulting higher.The corrected result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely low homocysteine result obtained on the immulite 2000 xpi.

Manufacturer Narrative

Initial mdr 2247117-2016-00009 was filed on (b)(4) 2016.Additional information (4/27/2016): a siemens field service engineer visited the customer site.The fse noticed that the grounding of the sample carousel was >20 ohm, so the connection of the grounding brush was adjusted, lowering the grounding to <1 ohm.The system is performing according to specifications.No further evaluation of the device is required.

• 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: 5453609
• MDR Text Key: 38774490
• Report Number: 2247117-2016-00009
• Device Sequence Number: 0
• Product Code: LPS
• Reporter Country Code: US
• 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,Followup
• Report Date: 05/05/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• 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: 04/27/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1