CONTOUR NEXT

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 2020-01-03 for CONTOUR NEXT manufactured by Ascensia Diabetes Care Us Inc..

Event Text Entries

[173924772] The customer stated that she did not use clean, flat and non-absorbent surface while performing control tests. As per the contour next control solution user guide, one of the testing technique is as follows: "squeeze a small drop of solution onto a clean, nonabsorbent surface. Do not apply control solution to your fingertip or to the test strip directly from the bottle. " the patient/family was the initial reporter , so personal information was not entered. Weight was left blank as the customer's weight was not provided. The model # was not provided.
Patient Sequence No: 1, Text Type: N, H10


[173924773] The customer reported that she ran control tests using the contour next ez meter and obtained readings of 187 mg/dl and 153 mg/dl. The meter did not automatically mark them as control tests, and so the readings will be displayed as blood results when accessing the meter's memory. There was no allegation of an adverse event. The customer was advised to return the control solution for evaluation. Replacement meter kit and test strips were sent to the customer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1810909-2020-00012
MDR Report Key9543961
Report SourceCONSUMER
Date Received2020-01-03
Date of Report2019-12-12
Date of Event2019-12-12
Date Mfgr Received2019-12-12
Device Manufacturer Date2019-02-01
Date Added to Maude2020-01-03
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 Phone9142361830
Manufacturer G1BIONOSTICS, INC. BUSINESS TRADE NAME: RNA MEDICAL
Manufacturer StreetREGISTRATION NUMBER: 1220649 7 JACKSON RD.
Manufacturer CityDEVENS MA 01434
Manufacturer CountryUS
Manufacturer Postal Code01434
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONTOUR NEXT
Generic NameQUALITY CONTROL MATERIAL
Product CodeJJX
Date Received2020-01-03
Lot Number9BV2G40
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
10 2020-01-03

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