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

Model Number	STRIP, KETONE 50CT
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1000113657-2022-00584
• Device Sequence Number: 6321835
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown