MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TESTOSTERONE (TSTO); TESTOSTERONE IMMUNOASSAY

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2014

Event Type  malfunction  

Event Description

Elevated advia centaur xp testosterone results were obtained on samples from two different patients.Redraw samples were tested for both patients two weeks later and the results were in the normal reference range.The discordant results were questioned.No other repeat testing was performed.No testosterone enhancement pharmaceuticals were taken by patients.The patients were tested as part of a routine physical.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant advia centaur xp testosterone result.

Manufacturer Narrative

The cause for the discordant advia centaur xp testosterone results is unknown.The cause for the elevated results maybe from pre-analytical factors during sample collection.The samples from the patients are not available for further testing and investigation.The instrument is performing within specification.No further evaluation of the device is required.The ifu states specimen collection and handling section: "before placing samples on the system, ensure that samples have the following characteristics: -samples are free of fibrin or other particulate matter.-samples are free of bubbles.".

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2014-00214 on august 14, 2014.On 10/14/2014 additional information: clarification was received regarding the initial result reported for patient 1.The initial result reported for patient 1 was 13,000 ng/dl.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP TESTOSTERONE (TSTO)
• Type of Device: TESTOSTERONE IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; east walpole, MA 02032 ; 5086604603
• MDR Report Key: 4008720
• MDR Text Key: 4693037
• Report Number: 1219913-2014-00214
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2014
• Device Model Number: N/A
• Device Catalogue Number: 05476206
• Device Lot Number: 167
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• 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: Initial
• Patient Sequence Number: 1