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

Model Number	STRIP, RLN TMX 50CTMG/DL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were returned - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on 25-oct-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 lo and low blood glucose test results.The customer is concerned with test results from results obtained of lo, 28 and 84 mg/dl.The customer¿s expected fasting blood glucose test result range is 200-400 mg/dl.The customer had not been using the proper testing technique (using alcohol pads).The customer feels well and did not report any symptoms.Customer stated that she had called 911 on (b)(6) 2021 due to the results of lo and 28 mg/dl.Fire rescue had arrived prior to the paramedics and had the customer eat a blueberry muffin with juice.The customer's blood glucose test result when the paramedics arrived had been 296 mg/dl non-fasting.A comparison test was performed using the true metrix air meter and the result had been 84 mg/dl non-fasting.No diagnosis was provided and customer was not transported to the hospital.Customer also had gone to her doctor's office the same day and had obtained another meter/test strips.During the call, a back to back blood test was not performed by the customer.The product is not stored according to specification; customer stated she had left her purse with her test kit in a hot car the week before.The test strip lot manufacturer¿s expiration date is 06/30/2022 and open vial date was not disclosed.The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was reviewed for previous test result history: (b)(6).
Additional Manufacturer Narrative
Sections with additional information as of 30-nov-2021: h3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: meter and test strips were returned for evaluation.Defect found on returned strips: low,e2,e5.Reported defect not reproduced on returned meter.Root cause: rc-061: storage outside specifications.

• 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: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 12759735
• Report Number: 1000113657-2021-00702
• Device Sequence Number: 3342912
• Product Code: NBW
• UDI-Device Identifier: 00021292012236
• UDI-Public: (01)00021292012236
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K150052
• 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,Followup
• Report Date (Section B): 11/30/2021

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: 06/30/2022
• Device Model Number: STRIP, RLN TMX 50CTMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZX4228S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/11/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 11/30/2021
• 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: Required Intervention
• Patient Sex: Unknown