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U.S. Department of Health and Human Services

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

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TRIVIDIA HEALTH INC TRUE METRIX; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER Back to Search Results
Model Number STRIP, WGN TMX 60CT 12/CASE MG/DL
Device Problem High Test Results (2457)
Patient Problems Hypoglycemia (1912); Syncope/Fainting (4411)
Event Date 02/15/2022
Event Type  Injury  
Event Description
Consumer reported complaint for high blood glucose test results.Son is calling on behalf of the customer.The customer is concerned with test results from results obtained of 238, 156, 105, 195 and 168 mg/dl.The customer does not know their expected blood glucose test result range.The customer feels well and did not report any symptoms.Past medical attention was reported; son stated that on (b)(6) 2022 customer had fainted and ems had been called.Customer was transported to the hospital where her blood glucose test result had been 18 mg/dl (fasting/non-fasting was not disclosed).The diagnosis was hypoglycemia; the medical treatment customer received was not disclosed.Customer remained in the er for six hours and then had been discharged; customer's blood glucose test result upon discharge was not disclosed.Customer had followed-up with her primary care physician.At that time, customer was taking tradjenta, glimepiride and glipizide.Customer's primary care physician had discontinued the glimepiride and the glipizide, but found that her blood glucose levels were ranging in the 200's, so the glipizide had been reinstated.During the call, a back to back blood test was not performed by the customer.The product is not stored according to specification (kitchen).The test strip lot manufacturer¿s expiration date is 03/29/2023 and open vial date is was not disclosed.The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was reviewed for previous test result history: (b)(6).
 
Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-020: user's test strip had poor storage.Note: manufacturer contacted customer in a follow-up call on 10-mar-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
 
Manufacturer Narrative
Sections with additional information as of 03-may-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: retention testing was performed using test strips from the same lot.Retention strips tested passed within specifications.
 
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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 Key13977488
MDR Text Key288389067
Report Number1000113657-2022-00186
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00021292009120
UDI-Public(01)00021292009120
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140100
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial,Followup
Report Date 05/03/2022
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
Device Operator Lay User/Patient
Device Expiration Date03/29/2023
Device Model NumberSTRIP, WGN TMX 60CT 12/CASE MG/DL
Device Catalogue NumberRE4H01-81
Device Lot NumberZY4483S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2022
Is the Reporter a Health Professional? No
Distributor Facility Aware Date03/07/2022
Initial Date Manufacturer Received 03/07/2022
Initial Date FDA Received04/01/2022
Supplement Dates Manufacturer Received04/05/2022
Supplement Dates FDA Received05/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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