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 2019-05-01 for N/A KETONE STRIPS NA manufactured by Trividia Health, Inc..

Event Text Entries

[145244881] (manufacturer narrative = t, corrected data = f) internal report: # (b)(4). Product not returned for evaluation. Most likely underlying root cause: mlc-20-user's test strip had poor storage. Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact at this time. Product notification letter sent to contact customer care.
Patient Sequence No: 1, Text Type: N, H10


[145244882] Consumer reported complaint for ketone strips, customer is concerned that color does not match chart on vial of ketone strips. The customer did not report symptoms neither medical attention. The ketone test strip lot manufacturer's expiration date is 05/28/2020 and open vial date is april 2019.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000113657-2019-00426
MDR Report Key8571598
Report SourceCONSUMER
Date Received2019-05-01
Date of Report2019-05-01
Date of Event2019-04-05
Date Mfgr Received2019-04-05
Date Added to Maude2019-05-01
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 ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameN/A
Generic NameBLOOD GLUCOSE SYSTEM
Product CodeJIN
Date Received2019-05-01
Model NumberKETONE STRIPS
Catalog NumberNA
Lot NumberAV449
Device Expiration Date2019-05-28
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 2019-05-01

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