MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUE PLUS; BLOOD GLUCOSE SYSTEM

Model Number TRUE PLUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 02/26/2018

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 mlc-28 there was not enough information to determine the mlurc.Note: manufacturer contacted customer in order to obtain more information and to ensure that the initial concern is resolved - able to establish contact with customer who indicated that she has pain to touch and bleeding on the finger.Stated it is numb and skin is cracked on the left side of her ring finger.Customer was going to see her doctor.Manufacturer contacted customer in a follow-up call to ensure that the customer symptoms improved and if the doctor visit resolved the initial concern - unable to establish contact at this time.

Event Description

Consumer reported complaint for lancets.Customer reported the complaint to the store and their representative called to report they were informed by customer that used the lancets in 2018 and that the first lancet used to prick her finger hurt more than any other time.Customer states the day this occurred was (b)(6) 2018 (the date was obtained from her logbook).Customer stated that she bleeds on and off from the prick and has for many months now.Customer stated she has pain from the site that radiates down her finger.Stated it is on the left side of her ring finger of her left hand and stated she sought medical attention.Customer was seen by her doctor and a skin care specialist, customer was prescribed fluocinonide 0.05%.Customer states during those 10 days the finger got better and hand no concerns, but once she stopped taking it the initial issue started again.Customer was given creams for her finger and stated she has to go to san diego to receive treatment.Customer stated that her concern is that due to being diabetic she is scared she may lose her finger.Customer stated the box was sealed, the lancet was intact and did not have physical defect, deformity or irregular appearance.

• Brand Name: TRUE PLUS
• 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 Key: 8769367
• MDR Text Key: 151002693
• Report Number: 1000113657-2019-00700
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• PMA/PMN Number: K000000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TRUE PLUS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1