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

Model Number	STRIP, RLN TMX 100CTMG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for evaluation.No defect was detected.Test strips were not returned for evaluation.Most likely underlying root cause: mlc-55: user had an inaccurate reference: competitor¿s meter: the end user is comparing results obtained from trividia¿s bgm system to the results from a competitor¿s bgm system.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from meter to meter comparison of 389 mg/dl using meter and 304 mg/dl using another device.Customer stated that he was concerned with the high result of 389 mg/dl so he had gone to the clinic to verify his blood glucose and the clinic had obtained the result of 304 mg/dl.Customer stated the clinic was right next to his work and the tests had been performed about five minutes apart, using the same hand, different finger.Customer also stated he does use alcohol prior to sticking his finger to test.The customer¿s expected fasting blood glucose test result range is 250 - 270 mg/dl.The customer feels well and did not report any symptoms.During the call, a back to back blood test was not performed by the customer; customer was not fasting at time of call.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 09/21/2020 and test strips were opened one-two weeks ago.The meter memory was reviewed for previous test result history: (b)(6).

• Brand Name: TRUE METRIX
• 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: 9365325
• Report Number: 1000113657-2019-10175
• Device Sequence Number: 14196509
• Product Code: NBW
• UDI-Device Identifier: 00021292012236
• UDI-Public: (01)00021292012236
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 11/22/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/21/2020
• Device Model Number: STRIP, RLN TMX 100CTMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MW3229S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Distributor Facility Aware Date: 10/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1