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

Model Number STRIP, TMX WGN 100CT12/CS MG/DL #383569

Device Problems Material Discolored (1170); Image Display Error/Artifact (1304); Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter was not returned for evaluation.Test strips were returned for evaluation.Defect was detected per qc investigation on 11/27/2019: discolored chemistry, lo, and e-5.Most likely underlying root cause: rc-061 storage outside specifications.Rc-072: vial left open for an extended period of time, rc-069: missing chemistry; user washed strips.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 Description

Consumer complaint of e-3 error; test strip error when she inserted the strips into the meter.Customer feels well and observed no symptoms.Medical intervention is not reported at the time of the call on (b)(6) 2019 as a result of the meter¿s readings.Blood test performed fasting during call on (b)(6) 2019 produced result of 141mg/dl fasting after blood sample applied to test strip (using another vial).Test strip lot manufacturer¿s expiration date is 04/22/2021 and open vial date is (b)(6) 2019.Adverse event not reported.

• 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: 9483857
• MDR Text Key: 218675229
• Report Number: 1000113657-2019-10236
• 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: K150052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/22/2021
• Device Model Number: STRIP, TMX WGN 100CT12/CS MG/DL #383569
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MW3550S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Distributor Facility Aware Date: 11/27/2019
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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