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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 10/04/2018
Event Type  malfunction  
Manufacturer Narrative
A siemens customer service engineer went on site and did not identify any mechanical issues related to the event. Preventative maintenance was performed. Precision of calibration and qc was acceptable and no fliers were observed. The high level control was out of the 2sd range by less than 0. 5 sd and does not represent a flier. The level 1 control was within range on the day of the elevated patient result. The level 1 control is closer in value to the patient sample value and does not indicate an issue with the calibration. Root cause was not identified. Preanalytical variables cannot be ruled out. The issue is isolated to one sample. The system is operational and no further action or investigation 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 reported an elevated advia centaur xp alpha-fetoprotein (afp) result. The physician questioned the result. The sample was repeated and the result was lower and aligned with previous results. 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 Key8000908
MDR Text Key126238107
Report Number1219913-2018-00265
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P020806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial
Report Date 10/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/15/2019
Device Model NumberN/A
Device Catalogue Number10309979
Device Lot Number09370199
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 Received10/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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