FDA Adverse Event Malfunction Summary report: N

TRUEMETRIX

MDR report key: 6508477 · Received April 20, 2017

Report

Report Number: 1000113657-2017-00702
Event Type: Malfunction
Date Received: April 20, 2017
Date of Event: February 28, 2017
Report Date: April 20, 2017
Manufacturer: TRIVIDIA HEALTH, INC.
Product Code: NBW
UDI-DI: 00010939719447
PMA / PMN Number: K140100
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. RETURNED TEST STRIPS EVALUATED WITH DEFECT FOUND. QC INVESTIGATION ON 4/12/2017 RESULTED IN DEFECT FOUND AND THE EVENT WAS DETERMINED TO BE REPORTABLE. MOST LIKELY UNDERLYING ROOT CAUSE OF HIGH CONTROL RESULTS IS DUE TO IMPROPER STORAGE: STRIP LEFT OUTSIDE OF VIAL FOR AN EXTENDED PERIOD OF TIME. MLURC OF E-2 ERRORS ARE DUE TO PTF INK SPLATTER AND A SCRATCH CROSSING THE ELECTRODES IN THE CONDUCTIVE PTF INK AREA (B)(4).

Description of Event or Problem · 1

CONSUMER REPORTED COMPLAINT FOR TEST STRIP NOT RECOGNIZING OR TEST STRIP NOT ABSORBING THE BLOOD. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER WAS USING PROPER TESTING TECHNIQUE. THE METER DOES NOT READ THE BLOOD. THE CUSTOMER PUTS THE STRIP INTO THE METER AND ONCE THE BLOOD IS ABSORBED THE METER TURNS OFF. DURING THE CALL ON (B)(6) 2017 THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2017 AS A RESULT OF THE METER'S READINGS. THE CUSTOMER WAS USING THE PROPER TEST STRIPS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2017 AND OPEN VIAL DATE WAS UNDISCLOSED. ADVERSE EVENT NOT REPORTED AT TIME OF CALL ON (B)(6) 2017.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290742	TRUEMETRIX	BLOOD GLUCOSE SYSTEM	NBW	TRIVIDIA HEALTH, INC.	TRUEMETRIX	MT1627	00010939719447

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 YR			SECOND THERAPY