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

Model Number STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL

Device Problem High Test Results (2457)

Patient Problems Vomiting (2144); Lethargy (2560)

Event Date 08/09/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for high blood glucose test results.Mother is calling on behalf of the customer, her 7 year old son.The customer is concerned with test results from results obtained of 91 and 107 mg/dl.The customer¿s expected fasting / non-fasting blood glucose test result range is not less than 72 mg/dl.The customer feels well and did not report any symptoms.Mother stated that yesterday, the customer was throwing up and was feeling lethargic and so she tested his blood glucose.Prior to yesterday, the last time the meter/strips were used was 8/2021.Mother stated that when customer was throwing up, she knew his blood glucose was low and she gave him 1/2 diet dr.Pepper and some frosting and it took his glucose level up.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The customer was not using the proper testing technique.During the call, a back to back blood test was not performed by the customer.The product is not stored according to specification (kitchen).The customer's test strips are expired: test strip lot manufacturer¿s expiration date is 06/27/2021 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: result 1: 91 mg/dl date: (b)(6) 2022 time: 8:11 pm non-fasting, result 2: 107 mg/dl date: (b)(6) 2022 time: 8:09 pm non-fasting, result 3: 74 mg/dl date: (b)(6) 2022 time: 2:47 pm fasting, result 4: 119 mg/dl date: (b)(6) 2022 time: 5:04 pm non-fasting, result 5: 110 mg/dl date: (b)(6) 2022 time: 8:15 pm non-fasting,.

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-aug-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Manufacturer Narrative

Sections with additional information as of 27-sept-2022: h3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: h10: customer returned expired test strips.Meter was returned for evaluation.Reported defect not reproduced on returned meter.Product evaluation has been completed and most likely underlying root cause selected.Most likely underlying root cause: mlc-012: product expired.

• Brand Name: TRUE METRIX
• 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: 15347181
• MDR Text Key: 305626714
• Report Number: 1000113657-2022-00466
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/27/2021
• Device Model Number: STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MW4020S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/09/2022
• Date Manufacturer Received: 09/07/2022
• 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