CELL-DYN RUBY ANALYZER 08H67-01

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 2019-11-29 for CELL-DYN RUBY ANALYZER 08H67-01 manufactured by Abbott Diagnostics Division.

MAUDE Entry Details

Report Number2919069-2019-00114
MDR Report Key9392095
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-09-30
Date Mfgr Received2019-11-15
Date Added to Maude2019-11-29
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 DIAGNOSTICS DIVISION
Manufacturer Street4551 GREAT AMERICA PARKWAY
Manufacturer CitySANTA CLARA CA 95054
Manufacturer CountryUS
Manufacturer Postal Code95054
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCELL-DYN RUBY ANALYZER
Generic NameAUTOMATED HEMATOLOGY ANALYZER
Product CodeGKZ
Date Received2019-11-29
Catalog Number08H67-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT DIAGNOSTICS DIVISION
Manufacturer Address4551 GREAT AMERICA PARKWAY SANTA CLARA CA 95054 US 95054


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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