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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  malfunction  
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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 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 Key12610816
Report Number1219913-2021-00461
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K031393
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
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number10995489
Device Lot Number494
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 Received09/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2021
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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