MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. KETONE STRIPS; BLOOD GLUCOSE SYSTEM

Model Number KETONE STRIPS

Device Problem Ambient Temperature Problem (2878)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2015

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Product not returned for evaluation.Most likely underlying root cause: tp-kt4 discoloration of test pad.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 1 of 9.

Event Description

Customer called in stating that she just bought a 50 ct ketone strips from the pharmacy and the vial was open.The strips turned a blackish color.No adverse event or medical intervention was reported.

Event Description

Customer called in stating that she just bought a 50 ct ketone strips from the pharmacy and the vial was open.The strips turned a blackish color.No adverse event or medical intervention was reported.

Manufacturer Narrative

(manufacturer narrative = f, corrected data = t) internal report #(b)(4).Correction: product was returned for evaluation and ketone strips evaluated.Most likely underlying root cause: tp-kt4 discoloration of test pad.Note: manufacturer reviewed and updated the risk analysis report for the ketone strips on (b)(6) 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 1 of 9.

Event Description

Customer called in stating that she just bought a 50 ct ketone strips from the pharmacy and the vial was open.The strips turned a blackish color.No adverse event or medical intervention was reported.

Manufacturer Narrative

(manufacturer narrative f, corrected data t) internal report (b)(4).Correction: product was returned for evaluation and ketone strips evaluated.Update: root cause: rc-061: storage outside specifications.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 1 of 9.

• Brand Name: KETONE STRIPS
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8505985
• MDR Text Key: 145038494
• Report Number: 1000113657-2019-00307
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• PMA/PMN Number: K000000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/29/2016
• Device Model Number: KETONE STRIPS
• Device Lot Number: AS283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 03/18/2019; 03/18/2019
• Supplement Dates FDA Received: 04/11/2019; 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SECOND THERAPY; SECOND THERAPY; SECOND THERAPY