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

Model Number KIT, TMX NFRS STARTERMG/DL

Device Problem Measurement System Incompatibility (2982)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Initial report involving recall of meter with serial number (b)(4) was submitted under manufacturer report number (b)(4).Note: manufacturer contacted customer in a follow-up call on 15-may-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.Customer stated he did not find the recall meter to send back to us.Customer is currently not at home and was asked to look for the meter and call us back.Note: manufacturer contacted customer in a follow-up call on 18-may-2020 to verify the recalled meter is returned to thi.Customer stated he thinks he discarded the meter.

Event Description

Consumer reported complaint for high results on alleged recalled meter.The customer is concerned with tests results obtained of 167mg/dl.The expected fasting blood glucose test result range is 140mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the call, a back to back blood test was not performed by the customer.The test strip lot manufacturers expiration date is 10/28/2021 and open vial date is about one week and a half ago.The meter memory was reviewed for previous test result history.(b)(6).Serial number reported is a recalled device due to measurement system incompatibility - mmol/l.However, customer stated reading from meter in mg/dl.

Manufacturer Narrative

Sections with additional information as of 27-aug-2020: h10: most likely underlying root cause: mlc-50: manufacturing or packaging process caused malfunction of user's test strip.

• Brand Name: TRUE METRIX AIR
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10135636
• MDR Text Key: 228350237
• Report Number: 1000113657-2020-00380
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292006075
• UDI-Public: (01)00021292006075
• Combination Product (y/n): N
• PMA/PMN Number: K150052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2021
• Device Model Number: KIT, TMX NFRS STARTERMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MX4221S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/12/2020
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1