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

Model Number	STRIP, RH TMX SUPPLY KIT10CT MG/DL
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Codes	Hyperglycemia (1905); Muscle Weakness/Atrophy (1967)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-020: user's test strip had poor storage.Note: customer contacted manufacturer on 23-apr-2026 - customer stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for error message (e-2).Nurse is calling on behalf of the customer.The customer feels well and did not report any symptoms.Caller advised the customer had symptoms of hypoglycemia (weakness) the day prior, (b)(6) 2026, and was taken to the hospital.The diagnosis was high blood glucose.Caller did not disclose what treatment customer had received.Customer had been discharged the day of the call, (b)(6) 2026.During the call, a back-to-back blood test was not performed by the customer.Per caller, the product is not stored according to specification (kitchen).The test strip lot manufacturer¿s expiration date is 06/29/2027 and per caller the open vial date is 2 weeks ago.The customer did not have another vial of test strips that had been stored and handled correctly.

• Brand Name: TRUE METRIX AIR
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 25112983
• Report Number: 1000113657-2026-00194
• Device Sequence Number: 15783307
• Product Code: NBW
• UDI-Device Identifier: 00021292009472
• UDI-Public: (01)00021292009472(17)270629(10)ZD6311S
• Combination Product (Y/N): N
• PMA/510(K) Number: K150052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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 Model Number: STRIP, RH TMX SUPPLY KIT10CT MG/DL
• Device Lot Number: ZD6311S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown