IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG N/A 10381323

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-01 for IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG N/A 10381323 manufactured by Siemens Healthcare Diagnostics Products, Limited.

MAUDE Entry Details

Report Number2432235-2020-00119
MDR Report Key9656363
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-02-01
Date of Report2020-02-27
Date of Event2019-12-14
Date Mfgr Received2020-02-03
Date Added to Maude2020-02-01
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 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242503
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
Manufacturer StreetGLYN RHONWY UK REGISTRATION #: 3002806944
Manufacturer CityLLANBERIS, GWYNEDD, LL554EL
Manufacturer CountryUK
Manufacturer Postal CodeLL55 4EL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG
Generic NameIMMUNOASSAY, TOXOPLASMA GONDII IGG
Product CodeLGD
Date Received2020-02-01
Model NumberN/A
Catalog Number10381323
Lot Number502
Device Expiration Date2020-02-29
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
Manufacturer AddressGLYN RHONWY LLANBERIS, GWYNEDD, LL554EL UK LL55 4EL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-01

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