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

Model Number ADVIA CENTAUR CP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/13/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer's site.The cse performed a total service call.The cse then recalibrated the reagent probe.The cause of the discordant, (b)(6) results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, (b)(6), results were obtained on a patient sample on an advia centaur cp instrument.A (b)(6) result was reported out to the physician(s).The physician(s) requested a redraw.The new sample was tested on the same advia centaur cp instrument, resulting (b)(6).The customer then tested the original sample, in duplicate, resulting (b)(6).A corrected report was issued to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, (b)(6) results.

• Brand Name: ADVIA CENTAUR CP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; registration #: 3008494306; neuwiesenstrasse 4; beringen 8222 ; SZ 8222
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6159952
• MDR Text Key: 62372068
• Report Number: 2432235-2016-00751
• Device Sequence Number: 0
• Product Code: LOL
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• 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
• Date Manufacturer Received: 11/14/2016
• 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