KETOSTIX 2883

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-26 for KETOSTIX 2883 manufactured by Ascensia Diabetes Care Us Inc..

MAUDE Entry Details

Report Number1810909-2019-00433
MDR Report Key9375319
Report SourceCONSUMER
Date Received2019-11-26
Date of Report2019-09-03
Date of Event2019-09-03
Date Mfgr Received2019-09-03
Device Manufacturer Date2019-01-01
Date Added to Maude2019-11-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactSHWETA GULATI
Manufacturer Street100 SUMMIT LAKE DRIVE
Manufacturer CityVALHALLA NY 10595
Manufacturer CountryUS
Manufacturer Postal10595
Manufacturer Phone9142962901
Manufacturer G1KIMBALL ELECTRONICS POLAND SP.Z O.O
Manufacturer StreetREGISTRATION NUMBER: 300805813 UL. POZNANSKA 1 C
Manufacturer CityTARNOWO PODGORNE WIELKOPOLSKIE, 62-080
Manufacturer CountryPL
Manufacturer Postal Code62-080
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKETOSTIX
Generic NameKETONE REAGENT STRIPS
Product CodeJIN
Date Received2019-11-26
Model Number2883
Catalog Number2883
Lot Number809076
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASCENSIA DIABETES CARE US INC.
Manufacturer Address100 SUMMIT LAKE DRIVE VALHALLA NY 10595 US 10595


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-11-26

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