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

Model Number	STRIP, TF WGN 50CTMG/DL 956970
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Codes	Hyperglycemia (1905); Loss of consciousness (2418)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 23-apr-2021 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 error message (e-3).Customer's test strips are expired: the test strip lot manufacturer¿s expiration date is 12/26/2020.Customer stated he had just purchased the test strips the day prior to the call.The customer did not have another vial of test strips that had been stored and handled correctly.At the time of the call, the customer felt well and did not report any symptoms.Customer stated he had gone to the hospital a few weeks prior to the call; customer did not recall the exact date.Customer stated he had passed out while at work and had woken up in the hospital.Customer stated he had not tested with the truefocus meter that day.Customer stated his blood glucose test result when at the hospital had been 749 mg/dl (fasting/non-fasting status was not disclosed).Customer stated he was diagnosed with hyperglycemia and was treated with two bags of iv insulin.Customer stated he had been hospitalized for three days and had been prescribed insulin when discharged.

• Brand Name: TRUE FOCUS
• 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: 11752249
• Report Number: 1000113657-2021-00289
• Device Sequence Number: 3091836
• Product Code: NBW
• UDI-Device Identifier: 00021292008956
• UDI-Public: (01)00021292008956
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131013
• 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): 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/26/2020
• Device Model Number: STRIP, TF WGN 50CTMG/DL 956970
• Device Lot Number: NV1001
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization