FDA Adverse Event Malfunction Summary report: N

TRUERESULT

MDR report key: 6128613 · Received November 28, 2016

Report

Report Number: 1000113657-2016-01908
Event Type: Malfunction
Date Received: November 28, 2016
Date of Event: November 3, 2016
Report Date: November 28, 2016
Manufacturer: TRIVIDIA HEALTH, INC.
Product Code: NBW
PMA / PMN Number: K080641
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PRODUCT NOT RETURNED FOR EVALUATION YET. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:USER HAD AN INACCURATE REFERENCE.

Description of Event or Problem · 1

COSTUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 52 MG/DL.THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 125 - 135 MG/DL. 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) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 90 MG/DL AND 110 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/23/2019 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET CORRECTLY): (B)(6). MEMORY CONCERNS:ALL LOW RESULTS. THE CUSTOMER IS TESTING FIVE TO SEVEN TIMES A DAY AND. THE CUSTOMER HAS NOT MADE ANY RECENT CHANGES IN THE DIET, EXERCISE REGIMEN, OR MEDICATION. THE CUSTOMER STATED THAT HAD A SODA LESS THAN TWO HOURS PRIOR TO PERFORMING THE BACK TO BACK BLOOD TESTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
780676	TRUERESULT	BLOOD GLUCOSE SYSTEM	NBW	TRIVIDIA HEALTH, INC.	TRUERESULT	PT2745

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 YR			SECOND THERAPY