UF1000I

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-04-11 for UF1000I manufactured by Sysmex 577.

Event Text Entries

[20646063] The instructions for use for this device indicate that the laser is a class i whereas the laser in the device is a class 3b. There was no report of injury for this event.
Patient Sequence No: 1, Text Type: D, B5


[21005398] Siemens has contacted the manufacturer of this device to inform them of this error.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1217157-2013-00063
MDR Report Key3071010
Report Source07
Date Received2013-04-11
Date of Report2013-03-27
Date of Event2013-03-27
Date Mfgr Received2013-03-27
Date Added to Maude2013-04-30
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 FDA0
Event Location0
Manufacturer ContactSTEVE ANDBERG
Manufacturer Street2 EDGEWATER DR.
Manufacturer CityNORWOOD MA 02062
Manufacturer CountryUS
Manufacturer Postal02062
Manufacturer Phone7812693655
Manufacturer G1SYSMEX
Manufacturer Street577 APTAKISIC ROAD
Manufacturer CityLINCOLNSHIRE IL 60069
Manufacturer CountryUS
Manufacturer Postal Code60069
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUF1000I
Generic NameNONE
Product CodeLKM
Date Received2013-04-11
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYSMEX 577
Manufacturer AddressAPTAKISIC ROAD LINCOLNSHIRE IL 60069 US 60069


Patients

Patient NumberTreatmentOutcomeDate
10 2013-04-11

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