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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS, 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 11/28/2018
Event Type  malfunction  
Manufacturer Narrative
The repeat testing was performed using the same sample, without additional centrifugation between initial and repeated measurements. The sample tube was a serum tube with gel separator from greiner bioone. The sample was centrifuged for 10 minutes at 2000xg after a clotting time of 30 minutes. The quality control and adjustment were valid. The performance of other tests was good, so system malfunction is unlikely. The cause for the discordant afp results is unknown. Siemens healthcare diagnostics is investigating. The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings".
 
Event Description
A discordant high advia centaur xp afp result was obtained for a patient sample. The patient sample was repeated and the results were lower. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant afp results.
 
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Brand NameADVIA CENTAUR XP AFP ASSAY
Type of DeviceAFP IMMUNOASSAY
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict avenue
tarrytown NY 10591 5097
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
333 coney street
e. walpole MA 02032
Manufacturer Contact
eiman sulieman
333 coney street
e. walpole, MA 02032
5086604603
MDR Report Key8171216
MDR Text Key131792563
Report Number1219913-2018-00302
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeAU
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 01/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2018
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 Received01/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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