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

Model Number ADVIA CENTAUR CP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The ccc reviewed the data provided.The customer's quality control (qc) was in at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed preventative maintenance and installed the test definition.The customer performed a precision run, resulting within range.The cause of the discordant, falsely depressed free thyroxine result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely depressed free thyroxine result was obtained on patient sample on an advia centaur cp instrument.The initial result was released to the physician(s), which was questioned.The same sample was repeated on the same advia centaur cp instrument, resulting higher.The customer sent the sample to a partner lab for testing.The partner lab result was higher than the initial result.The customer issued a corrected report for the repeat result on the original instrument to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed free thyroxine result.

• 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; gewerbestrasse 6; neuhausen am rheinfall 8212 ; SZ 8212
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6499099
• MDR Text Key: 73068555
• Report Number: 2432235-2017-00268
• Device Sequence Number: 0
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2012
• 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