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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CA 19-9 IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CA 19-9 IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN Back to Search Results
Model Number N/A
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2020
Event Type  malfunction  
Manufacturer Narrative
The customer has reported three discordant, low atellica im ca 19-9 results for a cancer patient in treatment. Siemens is investigating. The instructions for use (ifu) states the following, under limitations: "the concentration of ca 19 9 in a given specimen determined with assays from different manufacturers can vary because of differences in assay methods, calibration, and reagent specificity. Ca 19 9 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity. Therefore, it is important to use assay-specific values to evaluate quality control results. " "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. This assay is designed to minimize interference from heterophilic antibodies. Additional information may be required for diagnosis. " mdr 1219913-2020-00209 was filed for the same patient tested on a different date using a different system and a different lot. Mdr 1219913-2020-00211 was filed for the same patient tested on a different date using a different system and the same lot.
 
Event Description
A customer observed three low atellica im ca 19-9 results for a patient that were considered discordant compared to positive results from an alternate method and the patient's clinical condition. There are no reports of patient intervention or adverse health consequences due to the discordant low atellica im ca 19-9 results.
 
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Brand NameATELLICA IM CA 19-9
Type of DeviceIMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict avenue
tarrytown, ny
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
333 coney street
east walpole, ma
Manufacturer Contact
barry
333 coney street
east walpole, ma 
6604834
MDR Report Key10401033
MDR Text Key242591621
Report Number1219913-2020-00210
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K031393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/25/2020
Device Model NumberN/A
Device Catalogue Number10995489
Device Lot Number458
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/19/2020
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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