FDA Adverse Event Malfunction Summary report: N

TRUEMETRIX

MDR report key: 6361481 · Received February 27, 2017

Report

Report Number: 1000113657-2017-00400
Event Type: Malfunction
Date Received: February 27, 2017
Date of Event: February 8, 2017
Report Date: February 27, 2017
Manufacturer: TRIVIDIA HEALTH, INC.
Product Code: NBW
UDI-DI: 00021292006068
PMA / PMN Number: K140100
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. TEST STRIP (B)(4).

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 337 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 160 - 260 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) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 219 MG/DL USING TRUEMETRIX METER AND 221 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/15/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE CUSTOMER STATED HE HAS NOT HAD ANY CHANGES IN MEDICATIONS OR EXERCISE. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
145753	TRUEMETRIX	BLOOD GLUCOSE SYSTEM	NBW	TRIVIDIA HEALTH, INC.	TRUEMETRIX	MT2087	00021292006068

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 YR			SECOND THERAPY