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

Model Number	STRIP, WALGREENS 100CTTT #673261
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips (2 vials, same lot) were returned for evaluation.Product testing was performed and no defect found on returned meter.Defect found on returned strip vial id# (b)(4): physical defects of strips: discolored strips.Root cause: rc-069: missing chemistry; user washed strips.Defect found on returned strip vial id# (b)(4): control test results out of range (high) and e-5.Root cause: rc-061: storage outside specifications.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for test strip not absorbing the blood.Husband is calling on behalf of the customer.At the time of the call the customer felt well and did not report any symptoms.No medical attention related to the use of the product was reported.Customer was not using the proper testing technique (alcholol).The product is stored according to specification in the dining room.The test strip lot manufacturers expiration date is 09/30/2021 and open vial date is a few weeks prior to call.During the call, a blood test was attempted to be performed by the customer and the test strip did not absorb the blood.

• Brand Name: TRUETRACK
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11517775
• Report Number: 1000113657-2021-00182
• Device Sequence Number: 4881775
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 09/30/2021
• Device Model Number: STRIP, WALGREENS 100CTTT #673261
• Device Catalogue Number: A4H01-81
• Device Lot Number: RW5344S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Distributor Facility Aware Date: 02/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1