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

Model Number IMMULITE 2000 XPI

Device Problem Insufficient Information (3190)

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

Event Date 06/15/2015

Event Type  malfunction  

Manufacturer Narrative

The cause of the falsely low calcitonin result on the immulite 2000 xpi instrument is unknown.Siemens healthcare is investigating the issue.

Event Description

The customer has obtained a falsely low result on patient sample for the calcitonin assay on an immulite 2000 xpi.The same sample was run on an alternate platform and the result was higher.The initial result was reported and questioned by the physician (s) as it did not fit the clinical picture.The result on the alternate platform 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.

Manufacturer Narrative

Initial mdr 2247117-2015-00053 was filed on 10/52015.Additional information (10/13/2015): the customer contacted siemens customer care center (ccc).The customer indicated that based on interference testing for heterophilic antibodies the results have been discussed with the lab manager who has accepted the explanation for the discordant low calcitonin result.The customer has also indicated that the calcitonin assay is performing as per specifications and does not need any further assistance on this issue.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 NY 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS (REF#2517506); 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 5128401
• MDR Text Key: 27502093
• Report Number: 2247117-2015-00053
• Device Sequence Number: 1
• Product Code: JJQ
• 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: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• 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: 10/13/2015
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1