FDA Adverse Event Malfunction Summary report: N

METRIX AIR

MDR report key: 6508476 · Received April 20, 2017

Report

Report Number: 1000113657-2017-00701
Event Type: Malfunction
Date Received: April 20, 2017
Date of Event: March 9, 2017
Report Date: April 20, 2017
Manufacturer: TRIVIDIA HEALTH, INC.
Product Code: NBW
UDI-DI: 00041220009169
PMA / PMN Number: K150052
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INTERNAL REPORT # (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. RETURNED TEST STRIPS EVALUATED WITH DEFECT FOUND. QC INVESTIGATION ON 4/6/2017 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 TEST STRIP. UDI# (B)(4).

Description of Event or Problem · 1

CONSUMER REPORTED COMPLAINT FOR TEST STRIP NOT RECOGNIZING OR TEST STRIP NOT ABSORBING THE BLOOD. THE CUSTOMER WAS USING PROPER TESTING TECHNIQUE. THE METER WOULD NOT READ THE TEST SAMPLE AND THE SCREEN STILL SHOWED IT WAS READY TO TEST. 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 06/30/2017 AND OPEN VIAL DATE IS 03/02/2017. ADVERSE EVENT NOT REPORTED AT TIME OF CALL ON (B)(6) 2017.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290741	METRIX AIR	BLOOD GLUCOSE SYSTEM	NBW	TRIVIDIA HEALTH, INC.	METRIX AIR	MT1518	00041220009169

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 YR			SECOND THERAPY