MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP; CLINICAL CHEMISTRY ANALYZER

Model Number ADVIA CENTAUR XP

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 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The ccc reviewed the data provided.The ccc found that the customer's quality control (qc) was not within range when the patient sample was run.The ccc recalibrated the instrument and ran qc, resulting within range.The customer ran the patient sample, resulting higher.Siemens is investigating the event.

Event Description

A discordant, falsely depressed thyroid peroxidase result was obtained on a patient sample on an advia centaur xp instrument.The initial result was reported out to the physician(s).The customer repeated the same sample on the same advia centaur xp instrument, resulting higher.The customer repeated the same sample on the same advia centaur xp instrument again, resulting higher 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 (b)(6) thyroid peroxidase result.

Manufacturer Narrative

The initial mdr 2432235-2017-00204 was filed on march 20, 2017.Additional information (04/13/2017): the siemens headquarters support center (hsc) reviewed the event.The issue was corrected by performing calibration using a new calibrator.Calibration and quality control (qc) were run, resulting within range.The cause of the discordant, falsely depressed thyroid peroxidase result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; registration number: 8020888; chapel lane; swords, co, dublin ; EI
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6419498
• MDR Text Key: 70454492
• Report Number: 2432235-2017-00204
• Device Sequence Number: 0
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2010
• 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