ALINITY I PROCESSING MODULE 03R65-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-11-30 for ALINITY I PROCESSING MODULE 03R65-01 manufactured by Abbott Germany.

MAUDE Entry Details

Report Number3002809144-2019-00987
MDR Report Key9392248
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-11-30
Date of Report2019-11-30
Date of Event2019-08-27
Date Mfgr Received2019-11-07
Device Manufacturer Date2018-03-16
Date Added to Maude2019-11-30
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 ContactCHRISTIAN LEE
Manufacturer Street100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone224668-294
Manufacturer G1ABBOTT GERMANY
Manufacturer StreetMAX-PLANCK-RING 2
Manufacturer CityWIESBADEN 65205
Manufacturer CountryGM
Manufacturer Postal Code65205
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALINITY I PROCESSING MODULE
Generic NameAUTOMATED IMMUNOASSAY ANALYZER,
Product CodeJJE
Date Received2019-11-30
Catalog Number03R65-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT GERMANY
Manufacturer AddressMAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-30

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