IMMULITE 2000 HCG IMMULITE 2000 - HCG 10381194

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-24 for IMMULITE 2000 HCG IMMULITE 2000 - HCG 10381194 manufactured by Siemens Healthcare Diagnostics Products, Limited.

MAUDE Entry Details

Report Number2432235-2020-00192
MDR Report Key9748504
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-02-24
Date of Report2020-03-19
Date of Event2020-01-30
Date Mfgr Received2020-02-24
Date Added to Maude2020-02-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMR. MARDOCHEE TIMOLIEN
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN, NY
Manufacturer CountryUS
Manufacturer Phone5242503
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
Manufacturer StreetGLYN RHONWY UK REGISTRATION #: 3002806944
Manufacturer CityLLANBERIS, LL554EL
Manufacturer CountryUK
Manufacturer Postal CodeLL55 4EL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE 2000 HCG
Generic NameIMMULITE 2000 XPI - HUMAN CHORIONIC GONADOTROPIN (HCG)
Product CodeDHA
Date Received2020-02-24
Model NumberIMMULITE 2000 - HCG
Catalog Number10381194
Lot Number451
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
Manufacturer AddressGLYN RHONWY LLANBERIS, LL554EL EI LL55 4EL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-24

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