MAUDE Adverse Event Report: TRIVIDIA HEALTH INC KETONE; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number STRIP, KETONE 50CT

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Ketone test strips were not returned for evaluation.Most likely underlying root cause: mlc-1: user had an inaccurate reference.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.

Event Description

Consumer reported complaint for high ketone results.Aim medical supply representative and mother are calling on behalf of the customer, who is a (b)(6) year-old child.At the time of the call, the customer felt well and did not report any symptoms.Mother stated that on (b)(6) 2019 she had taken customer to the hospital due to ketone strips results obtained stating customer had large amounts of ketones in her urine.At the hospital a urine test was performed to check customer's urine for ketones.Mother stated a very trace amount, if any, were actually present in customer's urine sample.Customer did not require any treatment.The product is stored according to specification in the bedroom.The ketone test strip lot manufacturer¿s expiration date is 06/16/2020 and open vial date is 10/01/2019.Customer was using proper testing techniques.Customer was not willing to perform a urine test at the time of the call.

Manufacturer Narrative

Additional information as of 30-dec-2019.Added internal report reference number.Internal report reference number: (b)(4).Ketone test strips were returned for evaluation.No defect was detected.

• Brand Name: KETONE
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 9272018
• MDR Text Key: 207221987
• Report Number: 1000113657-2019-10118
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: (01)00021292008178
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/16/2020
• Device Model Number: STRIP, KETONE 50CT
• Device Lot Number: AV456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Distributor Facility Aware Date: 10/08/2019
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1