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

Model Number ADVIA CENTAUR CP

Device Problem False Negative Result (1225)

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

Event Date 05/14/2014

Event Type  malfunction  

Event Description

A (b)(6) result was obtained on a patient sample when repeat testing was performed by the customer.The patient's initial (b)(6) test result was positive and it is the laboratory's protocol to repeat initially (b)(6) test results with an index result between one and eleven.The patient sample was repeated a second time two days later and the hcv results were (b)(6).A result was reported.There was no report of patient intervention or adverse health consequences due to the (b)64) assay repeat result.

Manufacturer Narrative

A siemens customer service engineer (cse) was sent to the customer site for instrument inspection.After evaluation of the instrument and instrument data, the cse decontaminated the system including the acid and base lines, replaced the waste, water and wash 1 tubing from the system to the bulk bottles, lubricated the sample syringe, checked the probe calibrations, and cleaned the databases and defragmented the hard drives.The cause for the discordant hcv result is unknown.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; neuwiesenstrasse 4; registration number 3008494306; beringen, 8222 ; SZ 8222
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 3889276
• MDR Text Key: 4652480
• Report Number: 2432235-2014-00388
• Device Sequence Number: 1
• Product Code: OBF
• 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: 05/30/2014

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: Medical Technologist
• Device Model Number: ADVIA CENTAUR CP
• Device Catalogue Number: 086-A002-01
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 06/23/2014
• 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