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

Model Number ADVIA CENTAUR CP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Enzyme Elevation (1838)

Event Date 04/29/2015

Event Type  malfunction  

Event Description

A discordant, falsely elevated cardiac troponin i (tni-ultra) result was obtained on one patient sample on an advia centaur cp instrument.The discordant result was reported to the physician(s), and the patient was treated for acute coronary syndrome.The sample was repeated twice on the same instrument, resulting lower.The corrected result was reported to the physician(s).There are no reports of adverse health consequences due to the discordant, falsely elevated tni-ultra result.

Manufacturer Narrative

The cause of the discordant, falsely elevated tni-ultra result is unknown.Siemens is investigating this issue.

Manufacturer Narrative

The initial mdr 2432235-2015-00261 was filed on may 28, 2015.Additional information (05/04/15): a siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse did not find an instrument malfunction.Siemens is investigating this issue.

Manufacturer Narrative

The initial mdr 2432235-2015-00261 was filed on may 29, 2015.Supplemental mdr #1 2432235-2015-00261 was filed june 03, 2015.Additional information (07/17/2015): a siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse did not find an instrument malfunction.The cause of the discordant, falsely elevated tni-ultra result 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 ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 4803487
• MDR Text Key: 5892563
• Report Number: 2432235-2015-00261
• Device Sequence Number: 0
• Product Code: MMI
• Reporter Country Code: NL
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 05/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2015
• 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