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

Model Number STRIP, TMX WGN 50CT MG/DL #348014

Device Problem High Test Results (2457)

Patient Problem Polydipsia (2604)

Event Date 11/30/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting doctor due to meter results and symptom related to diabetes: thirst.Meter and test strips were returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-058: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Note 1: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure the customer's condition had improved - able to establish contact with customer who stated that she was still feeling symptom of thirst but that it was a medication side effect.Customer stated she has been experiencing this symptom since she had been prescribed jardiance three weeks prior.No additional medical intervention since the last call was reported.Customer stated that her doctor had not yet replied to her message sent on (b)(6) 2022.Note 2: 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 high blood glucose test results.The customer is concerned with test results from results obtained of 241, 183, 184, 173 and 182 mg/dl.Customer had initially also reported complaint for hi to coordinator; when contacted by technician, customer was unsure if what she had seen had been hi; a result of hi was not reviewed in the meter memory.The customer stated the results had been obtained using two vials, same lot number, of test strips.The customer¿s expected am fasting blood glucose test result range is 119-134 mg/dl.At the time of the call the customer reported feeling thirsty.Customer stated that a week and half ago while using the old vial test strips, she had sent a web note to her doctor due to the results obtained.Customer stated the doctor had increased her metformin dosage from 1 to 2 pills twice a day.Customer stated she had sent a note to her doctor this morning regarding the high results and symptom but her doctor has not yet replied.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 08/29/2023; customer stated she no longer has strips from old vial and it had been opened less than a month ago, customer stated the new vial had been opened (b)(6) 2022.The meter memory was reviewed for previous test result history (date/time not set, customer stated all are am results): result 1: 241 mg/dl date: 12/01 time: 12:41 pm non-fasting am (new vial).Result 2: 183 mg/dl date: 11/29 time: 7:00 am fasting (old vial).Result 3: 184 mg/dl date: 11/29 time: 6:53 am fasting (old vial).Result 4: 173 mg/dl date: 11/28 time: 7:06 am fasting (old vial).Result 5: 182 mg/dl date: 11/27 time: 6:25 am fasting (old vial).

Manufacturer Narrative

Sections with additional information as of 23-jan-2023: h6: updated fda¿s type, findings and conclusions codes.H10: retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.

• Brand Name: TRUE METRIX AIR
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• 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: 16027817
• MDR Text Key: 305941288
• Report Number: 1000113657-2022-00667
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150052
• 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,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2023
• Device Model Number: STRIP, TMX WGN 50CT MG/DL #348014
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZY4670S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/30/2022
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other