• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM AFP AFP IMMUNOASSAY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM AFP 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 10/20/2019
Event Type  malfunction  
Manufacturer Narrative
The cause for the discordant afp result is unknown. Siemens healthcare diagnostics is investigating. The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings. ".
 
Event Description
A customer obtained a discordant alpha-fetoprotein (afp) result for a patient sample on the atellica im 1300 instrument. The physician questioned the initial result. The same sample was retested and a lower result was obtained. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant afp result.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameATELLICA IM AFP
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
east walpole MA 02032
Manufacturer Contact
stacy loukos
333 coney street
east walpole, MA 02032
5086608576
MDR Report Key9324240
MDR Text Key220570206
Report Number1219913-2019-00239
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeNL
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,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/21/2020
Device Model NumberN/A
Device Catalogue Number10995441
Device Lot Number43716213
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 Received02/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-