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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOTICS, INC ADVIA CENTAUR XP AFP ASSAY AFP IMMUNOASSAY

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SIEMENS HEALTHCARE DIAGNOTICS, INC ADVIA CENTAUR XP AFP ASSAY AFP IMMUNOASSAY Back to Search Results
Model Number N/A
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2018
Event Type  malfunction  
Manufacturer Narrative
Since the repeat testing of the sample on the initial instrument resulted as <1 ng/ml, preanalytical variables cannot be ruled out for this sample. At this time, the issue appears isolated to one sample. No further evaluation of the device is required. The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. ".
 
Event Description
Customer observed an elevated result for advia centaur xp afp that was lower upon repeat testing. There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp afp result.
 
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Brand NameADVIA CENTAUR XP AFP ASSAY
Type of DeviceAFP IMMUNOASSAY
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOTICS, INC
511 benedict avenue
tarrytown NY 10591 5097
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC
333 coney street
east walpole MA 02032
Manufacturer Contact
louise mclaughlin
333 coney street
east walpole, MA 02032
5086604381
MDR Report Key7848012
MDR Text Key119801310
Report Number1219913-2018-00225
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K020806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/25/2019
Device Model NumberN/A
Device Catalogue Number10309979
Device Lot Number99956196
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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