FDA Adverse Event Malfunction Summary report: N

METRIX AIR

MDR report key: 6345818 · Received February 21, 2017

Report

Report Number: 1000113657-2017-00351
Event Type: Malfunction
Date Received: February 21, 2017
Date of Event: January 26, 2017
Report Date: February 21, 2017
Manufacturer: TRIVIDIA HEALTH, INC.
Product Code: NBW
UDI-DI: 00021292007447
PMA / PMN Number: K150052
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. (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 163, 206 AND 190 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 110 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 174 MG/DL AND 198 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE IS 01/19/2017. CUSTOMER IS INSULIN DEPENDENT. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: CUSTOMER CONCERNED WITH ALL RESULTS. THE CUSTOMER CALLED WITH CONCERNS REGARDING THEIR METER READING HIGH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
129159	METRIX AIR	BLOOD GLUCOSE SYSTEM	NBW	TRIVIDIA HEALTH, INC.	METRIX AIR	MT1914	00021292007447

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 YR			SECOND THERAPY