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

Model Number ADVIA CENTAUR CP

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/29/2015

Event Type  malfunction  

Event Description

The customer reported obtaining unflagged out of range quality control results on an advia centaur cp instrument.The customer provided one example.The customer only performs human chorionic gonadotropin (hcg) and progesterone (prg) tests on this system.There are no known reports of patient intervention or adverse health consequences due to unflagged out of range quality control results.

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).A siemens headquarters support center (hsc) specialist reviewed the instrument data.The hsc determined the customer ran quality controls with a sample type of "patient".The hsc determined the customer scheduled quality controls as type "0", indicating a patient sample instead of type "2" which is a quality control.The hsc instructed the customer to run quality controls as type "2".The cause of unflagged out of range quality controls is due to user error: the customer defined and scheduled quality controls as patients instead of quality controls.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; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; registration #: 3008494306; gewerbestrasse 6; neuhausen am rheinfall 8212, ; SZ
• Manufacturer Contact: john nelson ; 511 benedict ave; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 4537708
• MDR Text Key: 5519907
• Report Number: 2432235-2015-00090
• Device Sequence Number: 1
• Product Code: DHA
• 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: 01/29/2015

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
• Device Catalogue Number: 086-A002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: No
• 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