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

Model Number STRIP, CVS 100CT KETONE

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4) ketone test strips were returned for evaluation and pending qc investigation.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 color on ketone test strips result does not match chart.The customer did not report symptoms.Medical attention is not reported as a result.The product is incorrectly stored in the bathroom.During the call, a ketone urine test was performed by the customer.The ketone test strip lot manufacturer¿s expiration date is 03/31/2021 and open vial date is undisclosed.

Manufacturer Narrative

Sections with additional information as of 18-jun-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 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: 10051191
• MDR Text Key: 228442638
• Report Number: 1000113657-2020-00296
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)021292008178
• Combination Product (y/n): N
• PMA/PMN Number: K000000
• 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: 06/18/2020

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: 03/31/2021
• Device Model Number: STRIP, CVS 100CT KETONE
• Device Lot Number: AW511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Distributor Facility Aware Date: 04/15/2020
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1