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

Model Number IMMULITE 2000 XPI

Device Problems Detachment Of Device Component (1104); Contamination (1120)

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

Event Date 03/14/2014

Event Type  malfunction  

Event Description

The operator of immulite 2000 xpi instrument discovered that the cap that secures the water bottle probe and float assembly to the water bottle easily detaches.

Manufacturer Narrative

Siemens healthcare diagnostics is conducting a correction for the immulite 2000 and immulite 2000 xpi immunoassay systems water and liquid waste bottles received starting may 2013.Siemens has identified that the water and liquid waste bottle assemblies were manufactured with a quality issue.The smaller diameter opening of both bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.Urgent medical device correction (umdc) 2015-03-05 entitled "immulite 2000 and immulite 2000 xpi water and liquid waste bottles issue" was sent to customers in the united states and urgent field safety notice (ufsn) 3022 entitled "immulite 2000 and immulite 2000 xpi water and liquid waste bottles issue" was sent to customers outside the united states in march 2015.The umdc/ufsn describes how to identify a defective bottle and actions to take if a defective bottle is identified.

• Brand Name: IMMULITE 2000 XPI
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4627958
• MDR Text Key: 5659689
• Report Number: 2247117-2015-00015
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010053/S007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 XPI
• Device Catalogue Number: 030001-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2015
• 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
• Removal/Correction Number: 2247117-03/13/15-001-C
• Patient Sequence Number: 1