UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM TN,DXH 800 HEMATOLOGY SYSTEM 629029

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 2020-03-03 for UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM TN,DXH 800 HEMATOLOGY SYSTEM 629029 manufactured by Beckman Coulter.

MAUDE Entry Details

Report Number1061932-2020-00024
MDR Report Key9783200
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-03
Date of Report2020-03-03
Date of Event2020-01-28
Date Mfgr Received2020-02-03
Date Added to Maude2020-03-03
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. HARRY LONG
Manufacturer Street1000 LAKE HAZELTINE DRIVE M/S R590C
Manufacturer CityCHASKA MN 55318
Manufacturer CountryUS
Manufacturer Postal55318
Manufacturer Phone9523681224
Manufacturer G1BECKMAN COULTER
Manufacturer Street11800 SW 147TH AVENUE
Manufacturer CityMIAMI FL 331962031
Manufacturer CountryUS
Manufacturer Postal Code331962031
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Generic NameCOUNTER, DIFFERENTIAL CELL
Product CodeGKZ
Date Received2020-03-03
Model NumberTN,DXH 800 HEMATOLOGY SYSTEM
Catalog Number629029
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER
Manufacturer Address250 S. KRAEMER BLVD BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-03

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