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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 KIT, TEST, ALPHA-FETOPROTEIN FOR TESTICULAR CANCER; KIT, TEST, ALPHA-FETOPROTEIN

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP AFP ASSAY KIT, TEST, ALPHA-FETOPROTEIN FOR TESTICULAR CANCER; KIT, TEST, ALPHA-FETOPROTEIN 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 12/11/2018
Event Type  malfunction  
Manufacturer Narrative
The cause for the falsely elevated advia centaur xp alpha-fetoprotein (afp) patient result is unknown. The customer's assay calibration and quality controls (qc) were acceptable. A siemens application specialist was at the customer site previously, and observed an outlier when performing a precision check. A siemens customer service engineer (cse) checked the system, and no issues were observed. Siemens is investigating the event. The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. ".
 
Event Description
A falsely elevated advia centaur xp alpha-fetoprotein (afp) result was observed on a patient sample. The customer performed repeat afp testing on the same sample, and instrument without additional sample centrifugation, and the results were lower. The elevated afp result was not reported to the physician. There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp afp result.
 
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Brand NameADVIA CENTAUR XP AFP ASSAY
Type of DeviceKIT, TEST, ALPHA-FETOPROTEIN FOR TESTICULAR CANCER; KIT, TEST, ALPHA-FETOPROTEIN
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict avenue
tarrytown NY 10591 5097
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
333 coney street
east walpole MA 02032
Manufacturer Contact
stephen perry
333 coney street
east walpole, MA 02032
5086604163
MDR Report Key8199490
MDR Text Key131943777
Report Number1219913-2018-00307
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 01/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/15/2018
Device Model NumberN/A
Device Catalogue Number10309980
Device Lot Number041199
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 Received01/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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