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

Model Number ADVIA CENTAUR CP

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/11/2014

Event Type  malfunction  

Event Description

The customer reported that after a software update was performed on an advia centaur cp instrument, the (b)(6) quality control results were configured to run with control bracketing set to "1" instead of "4", enabling the instrument to run patient samples after one qc passed instead of four.The customer observed the issue and manually ran (b)(6) quality control levels 2, 3 and 4 on (b)(6) samples.There were no discordant (b)(6) results generated or released to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the (b)(6) quality control results configured to run with control bracketing set to "1".

Manufacturer Narrative

The siemens headquarters support center (hsc) was contacted by the customer.After analyzing the data, the hsc determined that the cause of the (b)(6) quality control bracket setting of "1" was due to the incorrect control bracket setting within the software.The problem was corrected by a siemens customer service engineer, who was dispatched to the customer site and changed the quality control bracket setting in the software from "1" to "4".The cse saved the change in the software and successfully ran (b)(6) qc.The instrument is performing within specifications.Further evaluation of the device is not required.

• Brand Name: ADVIA CENTAUR CP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; registration number: 300849430; gewerbestrasse 6; neuhausen am rheinfall 8212, s, ; SZ
• Manufacturer Contact: john nelson ; siemens healthcare diagnostics; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3930459
• MDR Text Key: 4573743
• Report Number: 2432235-2014-00417
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ADVIA CENTAUR CP
• Device Catalogue Number: 086-A002-01
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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