MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number TRUEMETRIX

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage(kitchen).Test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4)2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.

Event Description

Consumer reported complaint for erratic blood glucose test results.The customer is concerned with tests results from back to back blood tests of 82 and 141 mg/dl.The customer's expected fasting blood glucose test result is 85 mg/dl.Customer was testing on the same finger; customer was advised on proper testing technique.Customer is not concerned with high results.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The product is not stored according to specification and is stored in the kitchen; customer was advised on proper storage.The test strip lot manufacturer's expiration date is 08/27/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6).

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage(kitchen).Test strip udi# (b)(4).Note: manufacturer contacted customer on 6/15/2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.

Event Description

Consumer reported complaint for erratic blood glucose test results.The customer is concerned with tests results from back to back blood tests of 82 and 141 mg/dl.The customer's expected fasting blood glucose test result is 85 mg/dl.Customer was testing on the same finger; customer was advised on proper testing technique.Customer is not concerned with high results.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on 06/05/2018, a back to back blood test was not performed by the customer.The product is not stored according to specification and is stored in the kitchen; customer was advised on proper storage.The test strip lot manufacturer's expiration date is 08/27/2019 and open vial date is 06/03/2018.The meter memory was reviewed for previous test result history: result 1:128mg/dl; date: (b)(6) 2018 time:710pm fasting.Result 2:152mg/dl; date: (b)(6) 2018 time:709pm fasting.Result 3:122mg/dl; date: (b)(6) 2018 time:901pm fasting.Result 4:82mg/dl; date: (b)(6) 2018 time:312pm fasting.Result 5:141mg/dl; date: (b)(6) 2018 time:251pm fasting.

• Brand Name: TRUEMETRIX
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7650216
• MDR Text Key: 113008550
• Report Number: 1000113657-2018-00699
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292006051
• UDI-Public: (01)00021292006051
• Combination Product (y/n): N
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

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: 08/27/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SECOND THERAPY; SECOND THERAPY