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 07/30/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens field service engineer (fse) was sent to the customer site.The fse checked sample and reagent probe alignments; fluid dispenses; wash station performance; acid and base pumps and dispenses; and the luminometer.The fse performed dark counts and backgrounds.No issues were identified.The quality controls were run and the results were within range and good precision.The cause for the discordant tsh3-ultra result is possibly the rare variant of tsh.The instrument is performing within specification.No further evaluation of the device is required.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the limitations section: "as with any immuno-recognition measurement of a peptide, extremely rare genetic variants may exhibit varying degrees of detection.".

Event Description

A falsely low advia centaur xp tsh3-ultra result was obtained for a patient sample.The patient sample was tested for tsh and the results were as expected.The low result was not reported to the physician.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: 5888814
• MDR Text Key: 52547546
• Report Number: 1219913-2016-00150
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2017
• Device Model Number: N/A
• Device Catalogue Number: 10282378
• Device Lot Number: 288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2016
• 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