LIFECODES LIFESCREEN DELUXE LMX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-11-15 for LIFECODES LIFESCREEN DELUXE LMX manufactured by Immucor Gti Diagnostics, Inc..

Event Text Entries

[59966430] Customer complaint (pr# (b)(4)) received on 10/17/2016, where customer reported unexpected negative results with life codes lifescreen deluxe lot 3003946.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183608-2016-00007
MDR Report Key6104633
Report SourceFOREIGN,USER FACILITY
Date Received2016-11-15
Date of Report2016-10-17
Date of Event2016-10-17
Date Mfgr Received2016-10-17
Device Manufacturer Date2016-06-27
Date Added to Maude2016-11-15
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 ContactERIKA HEWITT
Manufacturer Street20925 CROSSROADS CIRCLE
Manufacturer CityWAUKESHA WI 531864054
Manufacturer CountryUS
Manufacturer Postal531864054
Manufacturer Phone2627541006
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIFECODES LIFESCREEN DELUXE
Generic NameLIFECODES LIFESCREEN DELUXE
Product CodeMZI
Date Received2016-11-15
Model NumberNA
Catalog NumberLMX
Lot Number3003946
Device Expiration Date2017-03-15
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerIMMUCOR GTI DIAGNOSTICS, INC.
Manufacturer Address20925 CROSSROADS CIRCLE WAUKESHA WI 531864054 US 531864054


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-15

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