MAUDE Adverse Event Report: TRIVIDIA HEALTH INC KETONE; NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)

Model Number STRIP, CVS KETONE 50CT

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2023

Event Type  malfunction  

Event Description

Consumer reported complaint of negative/no change trace results for the trueplus ketone test strips.Customer stated that the ketone test strips do not change color, they show negative and medium gray more than 15 seconds after he applies the urine.Customer stated that 3 or 4 weeks ago he was in ketosis (he wasn't having diabetic symptoms) and that he felt a lot of energy, but the ketone test strips didn't change color, they showed negative and more than 15 seconds later it change medium gray.The package had not been open or damaged when received by the customer.The product is not stored according to specification (bathroom).The test strip lot manufacturer¿s expiration date is 09/25/2023.Customer opened the ketone test strips 7 months ago (expired) and he has been using the product since then for his diet.At the time of the call the customer felt well and did not report any symptoms.Medical attention related to the use of the product was not reported.

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-006: passed open expiration date.Note 1: manufacturer contacted customer in a follow-up call on 03-aug-2023 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated he had not yet received the replacement products.Note 2: manufacturer contacted customer in follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 18-sep-2023: d9: device available for evaluation.H3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: ketone test strips were returned for evaluation.Product testing was performed and no defect found on returned ketone test strips.Most likely underlying root cause: mlc-006: passed open expiration date.

• Brand Name: KETONE
• Type of Device: NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
• 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
• MDR Report Key: 17545487
• MDR Text Key: 321648015
• Report Number: 1000113657-2023-00419
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)021292008178
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

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 Expiration Date: 09/25/2023
• Device Model Number: STRIP, CVS KETONE 50CT
• Device Lot Number: AA648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/21/2023
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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