TRUE METRIX STRIP, SUNMARK TMX 50CTMG/DL MM RE4H01-81

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 2020-03-31 for TRUE METRIX STRIP, SUNMARK TMX 50CTMG/DL MM RE4H01-81 manufactured by Trividia Health Inc.

MAUDE Entry Details

Report Number1000113657-2020-00191
MDR Report Key9908198
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-02
Date Facility Aware2020-03-02
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-31
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
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRUE METRIX
Generic NameSYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
Product CodeNBW
Date Received2020-03-31
Model NumberSTRIP, SUNMARK TMX 50CTMG/DL MM
Catalog NumberRE4H01-81
Lot NumberMW3361S
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 2020-03-31

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