N/A KETONE STRIPS NA

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 2019-04-12 for N/A KETONE STRIPS NA manufactured by Trividia Health, Inc..

Event Text Entries

[145096807] (manufacturer narrative = t, corrected data = f) internal report: # (b)(4). Product not returned for evaluation. Most likely underlying root cause: mlc-28 there was not enough information to determine the mlurc. Note: manufacturer is unable to reach to customer since no customer address on file nor email/phone information.
Patient Sequence No: 1, Text Type: N, H10


[145096808] Consumer reported complaint for discoloration of ketone strips pads. Customer emailed regarding ketone strips saying that found that the color that appears on the stick is very faint and dissimilar to the colors on the legend. It's almost impossible for to determine the results. The customer did not report symptoms neither medical attention. The product storage location is undisclosed. The ketone strip lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000113657-2019-00320
MDR Report Key8511859
Report SourceCONSUMER
Date Received2019-04-12
Date of Report2019-04-12
Date of Event2019-01-30
Date Mfgr Received2019-03-19
Date Added to Maude2019-04-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKAREN DEVINCENT
Manufacturer Street2400 NW 55TH COURT
Manufacturer CityFORT LAUDERDALE FL 33309
Manufacturer CountryUS
Manufacturer Postal33309
Manufacturer Phone954677-920
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameN/A
Generic NameBLOOD GLUCOSE SYSTEM
Product CodeJIN
Date Received2019-04-12
Model NumberKETONE STRIPS
Catalog NumberNA
Lot NumberN/A
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTRIVIDIA HEALTH, INC.
Manufacturer Address2400 NW 55TH COURT FORT LAUDERDALE FL 33309 US 33309


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-12

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