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

Model Number STRIP, KETONE 50CT

Device Problem Unsealed Device Packaging (1444)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Expired ketone test strips were returned.Unable to test.Internal evaluation has been completed by packaging and root cause selected.No abnormalities observed.Most likely underlying root cause: mlc-063: damaged during transit manufacturer contacted customer in a follow-up call on (b)(6)2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Event Description

Consumer reported complaint for open vial.Customer stated that she had purchased the ketone test strips that morning and that the box had been sealed but the vial was opened.The ketone test strips are expired - manufacturer¿s expiration date is 12/22/2021.Customer did not perform any tests using this vial.Customer stated that she got a second vial, and that vial is working and in date as per customer (she did not provide the lot # of the new bottle).The customer feels well and did not report any symptoms.No medical intervention related to the use of the product was reported.

• 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: 15751376
• MDR Text Key: 308027271
• Report Number: 1000113657-2022-00584
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 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
• Report Date: 11/08/2022

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: 12/22/2021
• Device Model Number: STRIP, KETONE 50CT
• Device Lot Number: AX586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Distributor Facility Aware Date: 10/12/2022
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/08/2022
• 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