MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL); TSH3-UL IMMUNOASSAY

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur xp tsh3-ultra result is the rare variant of tsh.An important product safety information bulletin (10814911) was sent to customers in the united states and an urgent field safety notice (10814910) was sent to customers outside of the united states, issued may 2013, that explains a rare variant of tsh, identified in a small cluster of patients, is not detected by siemens advia centaur systems tsh3-ultra assay.The customer communications also included a reminder that, for diagnostic purposes, the results obtained from these assays should always be used in combination with the clinical examination, patient medical history, and other findings.The instrument is performing within specification.No further evaluation of the device is required.

Event Description

Falsely low advia centaur xp tsh3-ultra ((tsh3-ul) results were obtained for samples from several patients.The patient samples were tested for tsh on the advia centaur xp and the results were higher.Select samples were tested on an alternate test method and the results were higher.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant tsh3-ultra result.

• Brand Name: ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL)
• Type of Device: TSH3-UL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 5264997
• MDR Text Key: 32632151
• Report Number: 1219913-2015-00189
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K083844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10282378
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2015
• 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: Initial
• Removal/Correction Number: 1219913-05/10/2013-002-C
• Patient Sequence Number: 1