MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR CP

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating the event.

Event Description

A discordant, falsely depressed thyroid stimulating hormone result was obtained on a patient sample on an advia centaur cp instrument.The initial result was reported out to the physician(s), which was questioned.The same sample was repeated on the same advia centaur cp instrument, resulting higher.The customer issued a corrected report to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed thyroid stimulating hormone result.

Manufacturer Narrative

The initial mdr 2432235-2017-00244 was filed on april 10, 2017.Correction (04/17/2017): a correction to patient results.

Event Description

A discordant, falsely elevated thyroid stimulating hormone result was obtained on a patient sample on an advia centaur cp instrument.The initial result was reported out to the physician(s), which was questioned.The same sample was repeated on the same advia centaur cp instrument, resulting lower.The customer re-spun the same sample and repeated the sample on the same advia centaur cp instrument, resulting lower than the initial result.The customer issued a corrected report to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated thyroid stimulating hormone result.

Manufacturer Narrative

Additional information (03/16/2017): the customer contacted the siemens technical support center (tsc) to report the discordant thyroid stimulating hormone ultra (tshu) result.A siemens headquarter support center (hsc) has reviewed the instrument and escalation data for this issue.Tsc checked the qc results were in range on (b)(6) 2017.On (b)(6) 2017 the error log was reviewed by the tsc and sample integrity error was identified.Tsc also stated that the acid and base cover was open.The primary reagent was placed on board on (b)(6) 2017 and qc was in range.When the second sample was repeated the result was similar to the first sample tested on (b)(6) 2017.The system was returned to operation and the discordant result could not be repeated.This is considered an isolated case.The cause of the discordant tsh result is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR CP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; registration #: 3008494306; neuwiesenstrasse 4; beringen 8212 ; SZ 8212
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6478572
• MDR Text Key: 72551468
• Report Number: 2432235-2017-00244
• Device Sequence Number: 0
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR CP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2015
• 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