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

Model Number STRIP, WALGREENSKETONE 50CT #496636

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

Ketone strips were returned for evaluation.Defect was detected.Most likely underlying root cause: rc-61: storage outside specifications.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.

Event Description

Consumer reported complaint for physical defect of ketone strips (discolored grey / color does not match chart on vial).Customer stated that she had purchased two vials of the same lot number of ketone strips last week; lot number aw477, manufacturer's expiration date of 10/22/2020.Customer stated that when she had opened both vials, the strips appeared grey.Customer had only used one strip and it stayed a dark grey color.The product is not stored according to specification and is stored in the bathroom.At the time of the call, the customer felt well and did not report any symptoms.Medical attention was not required at an earlier time.Customer was using proper testing techniques.Customer was not willing to perform a urine test during the call.

• 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: 9274066
• MDR Text Key: 207222580
• Report Number: 1000113657-2019-10121
• Device Sequence Number: 1
• Product Code: JIN
• 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: Replace
• Type of Report: Initial
• Report Date: 11/04/2019

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: 10/22/2020
• Device Model Number: STRIP, WALGREENSKETONE 50CT #496636
• Device Lot Number: AW477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Distributor Facility Aware Date: 10/09/2019
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/04/2019
• 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