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

Model Number	METER, AIR TVH TMX NFRSMG/DL
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Confusion/ Disorientation (2553)
Date of Event	08/14/2020
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-61: improper use / mishandled by end user.Note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - unable to establish contact with customer at this time.Product notification letter sent to contact customer care.
Event or Problem Description
Consumer reported complaint for dead meter.At the time of the call, the customer reported symptoms of disorientation and stuttering.Medical attention was not needed at the time of the call.Customer had changed the battery on day of call ((b)(6) 2020).During the call the truemetrix air meter did not turn on by using the power button or when a test strip was inserted.

• 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
• MDR Report Key: 10518703
• Report Number: 1000113657-2020-00667
• Device Sequence Number: 14248650
• Product Code: NBW
• UDI-Device Identifier: 00021292007447
• UDI-Public: (01)00021292007447
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/10/2020

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 Expiration Date: 01/27/2022
• Device Model Number: METER, AIR TVH TMX NFRSMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MX4344S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/10/2020
• 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: Other