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

Model Number IMMULITE 2000 XPI

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Venipuncture (2129)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).During troubleshooting, the ccc specialist determined that the microsample cup was punctured by the sample probe because of improper level sensing due to the operator using the incorrect sample rack for the tube top sample type.The ccc specialist informed the operator that the approved sample rack for that tube type must be utilized.The operator cleaned the sample probe and performed a dispense test and verified that there were no further issues.The cause of the sample probe puncturing the sample cup was a user error.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The operator of an immulite 2000 xpi instrument stated that the sample probe had punctured a microsample cup and aspirated the entire sample from the cup.The patient needed to be redrawn because there was not enough sample volume left for testing.It is unknown what tests were ordered for the patient.

• 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: 4943472
• MDR Text Key: 23019028
• Report Number: 2247117-2015-00042
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010053/S007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• 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: 07/02/2015
• 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