MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. 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 06/11/2015

Event Type  malfunction  

Event Description

Discordant results were obtained on patient samples tested for multiple methods on an advia centaur cp instrument.Discordant results were not reported to the physician(s), as the customer stated that results were not believable.Quality controls were out of range for all methods.It is unknown if repeat testing was performed.There are no reports of patient intervention or adverse health consequences due to the discordant results.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse replaced the wash 1 solution due to contamination and cleaned the luminometer due to base residue.The cause of the discordant results is unknown.The instrument is performing according to specifications.No further evaluation of the device is 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 #: 3008494306; neuwiesenstrasse 4; beringen, 8222 ; SZ 8222
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown 10591 ; 9145243105
• MDR Report Key: 4894270
• MDR Text Key: 6018866
• Report Number: 2432235-2015-00318
• 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: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 06/11/2015
• Initial Date FDA Received: 07/07/2015
• 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