FDA Adverse Event Malfunction Summary report: N

TRUEMETRIX

MDR report key: 6052013 · Received October 24, 2016

Report

Report Number: 1000113657-2016-01762
Event Type: Malfunction
Date Received: October 24, 2016
Date of Event: September 29, 2016
Report Date: October 21, 2016
Manufacturer: TRIVIDIA HEALTH, INC.
Product Code: NBW
PMA / PMN Number: K140100
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER AND RETURNED TEST STRIPS(2). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:USER HAD AN INACCURATE REFERENCE.

Description of Event or Problem · 1

CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 184, 245 AND 158 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-180 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 FASTING AND PRODUCED TEST RESULTS OF 163 AND 151 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/20017 AND OPEN VIAL DATE IS 9/27/2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET CORRECTLY): THE 184MG/DL (B)(6) 2016 12:00:00 PM FASTING: YES, THE 245MG/DL (B)(6) 2016 12:00:00 PM FASTING: YES, THE 158MG/DL (B)(6) 2016 12:00:00 PM FASTING: YES, THE 163MG/DL (B)(6) 2016 12:00:00 PM FASTING: YES, THE 151MG/DL (B)(6) 2016 12:00:00 PM FASTING: YES. MEMORY CONCERNS: 245MG/DL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
702215	TRUEMETRIX	BLOOD GLUCOSE SYSTEM	NBW	TRIVIDIA HEALTH, INC.	TRUEMETRIX	MT1869

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 YR			SECOND THERAPY