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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XPT IMMUNOASSAY ANALYZER Back to Search Results
Model Number ADVIA CENTAUR XPT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2017
Event Type  malfunction  
Manufacturer Narrative
The initial mdr was filed on 21-dec-2017. Additional information (05-apr-2018): siemens technical support laboratory performed in-house testing with alpha fetoprotein kit lots 04191 and 041199. Calibrations and quality controls were within acceptable ranges. The kit lots are performing within manufacturing specifications. Siemens is investigating the issue. Mdrs 2432235-2017-00531_s4, mdr 2432235-2017-00599_s2, mdr 2432235-2017-00625_s2, and mdr 2432235-2018-00156 were filed for the same issue.
 
Manufacturer Narrative
The cause of the discordant, falsely elevated afp result on one patient sample is unknown. Siemens is investigating the issue. Mdr 2432235-2017-00531_s3 was filed for the event occurred on (b)(6) 2017. Mdr 2432235-2017-00599_s1 was filed for the event occurred on (b)(6) 2017. Mdr 2432235-2017-00625_s1 was filed for the event occurred on (b)(6) 2017.
 
Event Description
A discordant, falsely elevated alpha-fetoprotein (afp) result was obtained on one patient sample on an advia centaur xpt instrument. The sample was repeated twice on the same instrument, resulting lower both times. One of the repeat results was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated afp result.
 
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Brand NameADVIA CENTAUR XPT
Type of DeviceIMMUNOASSAY ANALYZER
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
511 benedict ave
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS
manufacturing limited
registration number: 8020888
chapel lane, swords, co., dublin
EI
Manufacturer Contact
shweta gulati
511 benedict avenue
tarrytown, NY 10591
9145242870
MDR Report Key7139652
MDR Text Key250774581
Report Number2432235-2017-00660
Device Sequence Number0
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K141999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberADVIA CENTAUR XPT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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