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

Model Number ADVIA CENTAUR XP

Device Problem Missing Value Reason (3192)

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

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center (ccc).The precision check data provided from ten samples, shows the coefficient of variation is out of range.Siemens is investigating the issue.

Event Description

A discordant, falsely depressed ferritin (fer) result was obtained on a patient sample on an advia centaur xp instrument.The initial result was not reported out to the physician(s).The same sample was tested on the same advia centaur xp instrument in duplicate, resulting higher.The customer then ran the same sample in triplicate on an alternate advia centaur instrument, resulting higher than the original result.The customer released the first repeat 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 ferritin result.

Manufacturer Narrative

The initial mdr 2432235-2016-00525 was filed on august 26, 2016.Additional information (08/05/2016): a siemens customer service engineer (cse) was dispatched to the customer's site.The cse replaced the ancillary probe.The cse then ran quality control (qc), which resulted in range.The cause of the discordant, falsely depressed ferritin 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 ; 9145252406
• MDR Report Key: 5909278
• MDR Text Key: 53295004
• Report Number: 2432235-2016-00525
• Device Sequence Number: 0
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/23/2016

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 XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2007
• 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
• Patient Age: 33 YR