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

Model Number ADVIA CENTAUR CP

Device Problem Mechanical Problem (1384)

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

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse replaced tubes from the peristaltic pump 3 and both rinsing block assemblies.The cse then cleaned the luminometer.The cse checked the reagent and sample probes' position and dispense volume of acid and base.The cause of the discordant sex hormone-binding globulin (shbg) result is unknown.Siemens is investigating this issue.

Event Description

A discordant sex hormone-binding globulin (shbg) patient result was obtained on an advia centaur cp instrument.The discordant result was not reported to the physician(s).The sample was repeated on the same advia centaur cp instrument.There are no known reports of patient intervention or adverse health consequences due to the discordant shbg result.

Manufacturer Narrative

The initial mdr 2432235-2016-00255 was filed on may 20, 2016.Additional information was received on 07/26/2016: no other discordant results occurred on the system since customer service engineer (cse) was at the customer's site.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 ave.; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; registration #: 3008494306; gewerbestrasse 6; neuhausen am rheinfall, 8212 ; SZ 8212
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5669843
• MDR Text Key: 45627892
• Report Number: 2432235-2016-00255
• Device Sequence Number: 0
• Product Code: CDZ
• Reporter Country Code: GM
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• 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
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2009
• 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