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

Model Number STRIP, RITE AID KT 50CT

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Products were returned and pending qc evaluation.Note: manufacturer contacted customer in a follow-up call on 12-aug-2020 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.Customer purchased the trueplus ketone strips in (b)(6) 2020.The package had not been open or damaged when received.The product is stored according to specification in the hallway/linen closet.The manufacturer's expiration date is 01/31/2021 and open vial date is (b)(6) 2020.At the time of the call the customer felt well and did not report any symptoms.Customer had tested on (b)(6) 2020 and the result was light purple (moderate-high).Customer stated she had not been feeling her best and had thought her blood glucose was elevated.Customer stated she called her endocrinologist on tuesday, (b)(6) 2020 and was told to observe herself and go to the hospital if the ketone test strips continued to show moderate-high.Customer stated she went to the hospital on (b)(6) 2020, was tested for ketones and test came back negative at the hospital.Customer stated her blood glucose test result at the hospital was 190 mg/dl non-fasting with no symptoms.Customer stated she came home, performed a test with the trueplus ketone test strips and the result was moderate-high.Customer was using the proper testing techniques.At the time of the call the customer declined to perform a urine test.

Manufacturer Narrative

Sections with additional information as of 11-sep-2020: h6: updated fda's method, result, and conclusion codes.H10: ketone test strips were returned for evaluation; no defect was detected.H10: most likely underlying root cause: mlc-001: user had an inaccurate reference.Corrected sections as of 11-sep-2020: h1: type of reportable event corrected from "malfunction" to "serious injury".

• Brand Name: KETONE TEST STRIPS
• 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: 10405370
• MDR Text Key: 222173467
• Report Number: 1000113657-2020-00578
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)021292008178
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

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: 01/31/2021
• Device Model Number: STRIP, RITE AID KT 50CT
• Device Lot Number: AW499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Distributor Facility Aware Date: 07/16/2020
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other