FC 500 FLOW CYTOMETER TN, FC500 FLOW CYTOMETER 100-240V, 50/60HZ 626553

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 2020-02-26 for FC 500 FLOW CYTOMETER TN, FC500 FLOW CYTOMETER 100-240V, 50/60HZ 626553 manufactured by Beckman Coulter.

MAUDE Entry Details

Report Number1061932-2020-00021
MDR Report Key9759669
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-02-26
Date of Report2020-02-26
Date of Event2020-02-05
Date Mfgr Received2020-02-10
Device Manufacturer Date2008-07-01
Date Added to Maude2020-02-26
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
Remedial ActionRC
Previous Use Code3
Removal Correction Number2050012-0108/2018-001C
Event Type3
Type of Report3

Device Details

Brand NameFC 500 FLOW CYTOMETER
Generic NameCOUNTER, DIFFERENTIAL CELL
Product CodeGKZ
Date Received2020-02-26
Model NumberTN, FC500 FLOW CYTOMETER 100-240V, 50/60HZ
Catalog Number626553
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
10 2020-02-26

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