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

Model Number ADVIA CENTAUR XP

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/02/2015

Event Type  malfunction  

Event Description

Discordant ferritin (fer), carcinoembryonic antigen (cea), cancer antigen -125 (ca - 125), triiodothyronine (t3), thyroxine (t4) and triiodothyronine uptake (tup) results were obtained on multiple patient samples on an advia centaur xp instrument.The initial results were reported to the physician(s).The samples were repeated on the same system.The corrected results were reported to the physician(s).There are no known reports of adverse health consequences or patient intervention due to the discordant fer, cea, ca - 125, t3, t4 and tup 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 determined that the instrument generated a cuvette sample integrity error during the time of the event.The cse checked and adjusted the sample probe bottom calibration and the sample probe dilution bottom calibration.The cse also cleaned and lubricated the sample probe vertical gear.The customer successfully ran quality controls.The cause of the discordant fer, cea, ca - 125, t3, t4 and tup results is unknown.The instrument is performing within specifications.Further evaluation of the device is not required.

Manufacturer Narrative

The initial mdr 2432235-2015-00048 was filed on january 28th, 2015.Corrected information (01/29/2015): ferritin (fer), thyroxine (t4) and triiodothyronine uptake (tup) result units.Ferritin (fer) results: ng/ml were initially reported as ug/l.Thyroxine (t4) results: ug/dl were initially reported as ng/dl.Triiodothyronine uptake (tup) results: % were initially reported as mg/l.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords co dublin, ; EI
• Manufacturer Contact: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 4461501
• MDR Text Key: 21329347
• Report Number: 2432235-2015-00048
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2015

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: Other
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A010
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 01/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2011
• 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