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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 Ambient Temperature Problem (2878)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2017
Event Type  malfunction  
Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report: # (b)(4).Product returned for evaluation.Root cause: discoloration of test pad due to improper storage.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 that she arrived from vacation on (b)(6) 2017.Customer states her ketosis strips were in her mailbox.The package was tracked and it was delivered on (b)(6) 2017.Customer is not comfortable using them being that they were left out in the sun for such a long time.Will reship the ketone strips for customer satisfaction.Note: manufacturer reviewed and updated the risk analysis report for the ketone strips on march 2019.Customer complaints for open vial were reviewed for possible mdr based on internal update of the risk report and the severity of harm, the complaint is reportable, however no adverse event or medical intervention was reported at the time of the call.Complaint 7 of 9.
 
Event Description
Customer says that she purchased 100 count box of ketone test strips.Customer says that the lid on one of the vials was not completely sealed.Customer also says she is no longer sure which vial it was since she sealed it back up.No adverse event or medical intervention was reported.
 
Manufacturer Narrative
(manufacturer narrative = t, corrected data = t) internal report: (b)(4).Product returned for evaluation.Update: root cause (rc): rc-061: storage outside specifications note 1: 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 that she arrived from vacation on (b)(6) 2017.Customer states her keytones strips were in her mailbox.The package was tracked and it was delivered on (b)(6) 2017.Customer is not comfortable using them being that they were left out in the sun for such a long time.Will reship the ketone strips for customer satisfaction.Note 2: manufacturer reviewed and updated the risk analysis report for the ketone strips on march 2019.Customer complaints for open vial were reviewed for possible mdr based on internal update of the risk report and the severity of harm, the complaint is reportable, however no adverse event or medical intervention was reported at the time of the call.Complaint 7 of 9.
 
Event Description
Customer says that she purchased 100 count box of ketone test strips.Customer says that the lid on one of the vials was not completely sealed.Customer also says she is no longer sure which vial it was since she sealed it back up.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
MDR Report Key8506929
MDR Text Key145038387
Report Number1000113657-2019-00313
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 07/12/2019
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 NumberAU352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2017
Was the Report Sent to FDA? No
Event Location Home
Initial Date Manufacturer Received 03/18/2019
Initial Date FDA Received04/11/2019
Supplement Dates Manufacturer Received03/18/2019
Supplement Dates FDA Received07/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SECOND THERAPY; SECOND THERAPY
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