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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP; IMMUNOASSAY ANALYZER Back to Search Results
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 Consequences Or Impact To Patient (2199)
Event Date 07/19/2014
Event Type  malfunction  
Event Description
Discordant, falsely elevated troponin ultra (tni ul) results were obtained on one patient sample on an advia centaur xp instrument.The patient sample was initially run in triplicate and the first two replicates resulted high, then the third replicate resulted lower.The same sample was then repeated on the same instrument and another advia centaur system, resulting lower on both.The falsely elevated results were not reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant tni ultra results.
 
Manufacturer Narrative
A siemens customer service engineer (cse) was sent to the customer site for instrument inspection.The cause for the falsely elevated troponin results is unknown.Siemens is investigating the issue.
 
Manufacturer Narrative
Siemens filed initial mdr 2432235-2014-00473 on 13-aug-2014 and a follow up/supplemental report with mfr report # 2432253-2014-00473 on 10-oct-2014.Correction (12-dec-2019): the mfr report # for the follow up/supplemental report should have been 2432235-2014-00473.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 2432253-2014-00473 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.
 
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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 Key4006743
MDR Text Key4710929
Report Number2432235-2014-00473
Device Sequence Number1
Product Code MOI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971418
Number of Events Reported1
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 NumberADVIA CENTAUR XP
Device Catalogue Number078-A010-04
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/19/2014
Initial Date FDA Received08/13/2014
Supplement Dates Manufacturer Received12/12/2019
Supplement Dates FDA Received12/17/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/18/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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