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

Model Number STRIP, CVS KETONE 50CTDIET

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Most likely underlying root cause: mlc-20: user's test strip had poor storage.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 ketone test strips are not matching the response printed on label.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification and it is stored in the bathroom.During the call, a ketone test was not performed by the customer.The ketone test strips lot manufacturer¿s expiration date is 12/27/2020 and open vial date is a week ago.

Manufacturer Narrative

Sections with additional information as of 28-aug-2020: h6: updated fda's method, result, and conclusion codes.H10: ketone test strips were returned for evaluation; no defect was detected.

• 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: 10142761
• MDR Text Key: 194806275
• Report Number: 1000113657-2020-00386
• 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: 08/28/2020

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: 12/27/2020
• Device Model Number: STRIP, CVS KETONE 50CTDIET
• Device Lot Number: AW489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Distributor Facility Aware Date: 05/14/2020
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1