CELL-DYN SAPPHIRE ANALYZER 08H00-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2020-03-23 for CELL-DYN SAPPHIRE ANALYZER 08H00-01 manufactured by Abbott Diagnostics Division.

MAUDE Entry Details

Report Number2919069-2020-00009
MDR Report Key9867831
Report SourceHEALTH PROFESSIONAL,STUDY
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-03-05
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-23
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 SAPPHIRE ANALYZER
Generic NameAUTOMATED HEMATOLOGY ANALYZER
Product CodeGKZ
Date Received2020-03-23
Model Number08H00-01
Catalog Number08H00-01
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 2020-03-23

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