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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. N/A; BLOOD GLUCOSE SYSTEM
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TRIVIDIA HEALTH, INC. N/A; BLOOD GLUCOSE SYSTEM Back to Search Results
Model Number KETONE STRIPS
Device Problem Display Difficult to Read (1181)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2019
Event Type  malfunction  
Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report: # (b)(4).Product returned for evaluation, defect found - discolored grey pads.Final root cause investigation has been completed rc-061 storage outside specifications.Note: manufacturer contacted customer in a follow-up call to ensure that the replacement products resolved the initial concern - able to establish contact with customer who indicated is comfortable with the replacement product.
 
Event Description
Customer called in stating that the ketone strips looked discolored.No additional information was provided.No adverse event or medical intervention was reported.
 
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Brand Name
N/A
Type of Device
BLOOD GLUCOSE SYSTEM
Manufacturer (Section D)
TRIVIDIA HEALTH, INC.
2400 nw 55th court
fort lauderdale FL 33309
Manufacturer Contact
karen devincent
2400 nw 55th court
fort lauderdale, FL 33309
954677-920
MDR Report Key8553076
MDR Text Key145238314
Report Number1000113657-2019-00393
Device Sequence Number1
Product Code JIN
Combination Product (y/n)N
PMA/PMN Number
K000000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberKETONE STRIPS
Device Lot NumberAV441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2019
Was the Report Sent to FDA? No
Event Location Home
Initial Date Manufacturer Received 04/01/2019
Initial Date FDA Received04/25/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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