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

Model Number	KIT, TMX NFRS STARTERMG/DL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-28: there was not enough information to determine the mlurc.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.Product notification letter sent to contact customer care.
Event or Problem Description
Husband is calling on behalf of the customer stating that customer had been using the truemetrix meter and that it is no longer working; husband was unsure of the exact issue with the truemetrix meter.Husband stated that customer had been in the hospital and then rehab for a few weeks and at recently returned home.Husband stated that customer has health issues and that the medical attention could have been related to her diabetes.Husband declined to provide any more details.Customer did not have any strips and husband stated she would be getting from the pharmacy the next day and that he would call back.Husband did not want to provide a contact telephone number.

• 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: 10479626
• Report Number: 1000113657-2020-00635
• Device Sequence Number: 19584066
• Product Code: NBW
• UDI-Device Identifier: 00021292006075
• UDI-Public: (01)00021292006075
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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 Model Number: KIT, TMX NFRS STARTERMG/DL
• Device Catalogue Number: RE4H01-81
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention