IMMULITE 2000 XPI - SPE 10380875

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-07 for IMMULITE 2000 XPI - SPE 10380875 manufactured by Siemens Healthcare Diagnostics Products, Limited.

MAUDE Entry Details

Report Number2432235-2019-00201
MDR Report Key8680713
Date Received2019-06-07
Date of Report2019-10-16
Date of Event2019-04-25
Date Mfgr Received2019-09-30
Date Added to Maude2019-06-07
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, LL554EL
Manufacturer CountryUK
Manufacturer Postal CodeLL55 4EL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE 2000 XPI - SPE
Generic NameIMMULITE 2000 XPI - SPE
Product CodeDHB
Date Received2019-06-07
Model NumberIMMULITE 2000 XPI - SPE
Catalog Number10380875
Lot Number717
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 2019-06-07

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