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

Model Number STRIP, KETONE 50CT

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

Pending packaging investigation.

Event Description

Consumer reported complaint for open vial of ketone strips.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.During the call a ketone test was not performed by the customer (dog).The test strip lot manufacturer¿s expiration date is 12/31/2020 and open vial date is undisclosed.

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone vial was not returned for evaluation.Complaint was forwarded to packaging based on complaint's description for investigations.No product was returned to thi.Internal evaluation has been completed by packaging and no abnormalities observed.Most likely underlying root cause: (b)(4): user error caused or contributed to event.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.No product notification letter sent since no customer address on file.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 9285518
• MDR Text Key: 207223758
• Report Number: 1000113657-2019-10129
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)021292008178
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/24/2019

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: 12/31/2020
• Device Model Number: STRIP, KETONE 50CT
• Device Lot Number: AW492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/10/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 12/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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