SIEMENS ATELLICA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-25 for SIEMENS ATELLICA manufactured by Siemens Healthcare Diagnostics, Inc..

MAUDE Entry Details

Report NumberMW5090047
MDR Report Key9124028
Date Received2019-09-25
Date of Report2019-09-19
Date of Event2019-09-19
Date Added to Maude2019-09-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameSIEMENS ATELLICA
Generic NameENZYME IMMUNOASSAY, PHENCYCLIDINE
Product CodeLCM
Date Received2019-09-25
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS, INC.

Device Sequence Number: 2

Brand NameSIEMENS ATELLICA
Generic NameENZYME IMMUNOASSAY, PHENCYCLIDINE
Product CodeLCM
Date Received2019-09-25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.