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

Model Number	KIT, TMX NFRS STARTERMG/DL
Medical Device Problem Code	Measurement System Incompatibility (2982)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• 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: 10135636
• Report Number: 1000113657-2020-00380
• Device Sequence Number: 19796632
• Product Code: NBW
• UDI-Device Identifier: 00021292006075
• UDI-Public: (01)00021292006075
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1