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

Model Number ADVIA CENTAUR XP

Device Problems False Reading From Device Non-Compliance (1228); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/16/2014

Event Type  malfunction  

Event Description

A discordant, falsely elevated troponin ultra (tni ul) result was obtained on the second sample from one patient on an advia centaur xp instrument.The patient was admitted due to the falsely elevated result.The physician questioned the elevated troponin result as it did not correlate with the results from the electro cardio gram (ekg).The patient sample was repeated on the original system and on another advia centaur system and the results were lower.There are no known reports of patient intervention or adverse health consequences due to the discordant tni ultra 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 checked the wash block functions, acid and base output volumes, and reagent probe 2 cuvette calibration positioning.The ancillary probe, ancillary plunger, aspirate probe 1 and probe 2 pinch valves were replaced.There was some corrosion observed on the power connector of pinch valve 2 which was cleaned.The sample probe, ancillary probe, and reagent probe 2 calibration positions were adjusted.The cse ran controls to verify instrument performance.The instrument is performing within specifications.The cause for the falsely elevated troponin result is unknown.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2014-00469 on 13-aug-2014 and a follow up/supplemental report with mfr report # 2432253-2014-00469 on 10-oct-2014.Correction (12-dec-2019): the mfr report # for the follow up/supplemental report should have been 2432235-2014-00469.The mfr report # was updated to reflect this information.The information documented in the follow up/supplemental report submitted on 10-oct-2014 can be found below: siemens filed the initial mdr 2432253-2014-00469 on august 13, 2014.Additional information (09/17/2014): a siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data and troubleshooting troponin imprecision, the cse replaced the ancillary probe, ancillary plunger, aspirate probe 1 pinch valve, aspirate probe 2 pinch valve, index mechanism, servo motor, servo processing computer board low level controller, ionizer and the incubation ring.The cse cleaned the pinch valve 2 power connector due a buildup of corrosion and performed system decontamination.The cause for the discordant troponin results is unknown.The instrument is operational and performing within specifications.No further investigation is required.

• 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 LTD.; chapel lane, swords, co.; registration number 8020888; dublin, ; EI
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 4006449
• MDR Text Key: 4778663
• Report Number: 2432235-2014-00469
• 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,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

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 Health Care Professional
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A010-04
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 08/13/2014
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2007
• 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