FDA Adverse Event Malfunction Summary report: N

METRIX AIR

MDR report key: 8588140 · Received May 7, 2019

Report

Report Number: 1000113657-2019-00464
Event Type: Malfunction
Date Received: May 7, 2019
Date of Event: April 12, 2019
Report Date: May 7, 2019
Manufacturer: TRIVIDIA HEALTH, INC.
Product Code: NBW
UDI-DI: 00021292007720
PMA / PMN Number: K150052
Report Source: Manufacturer report
Reporter Location: FL
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-18- USER HAS HIGH GLUCOSE VALUE. TEST STRIP UDI#: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CONTACT CUSTOMER CARE.

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 180, 153, 199, 210 AND 174 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 102 - 150 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 A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/17/2020 AND OPEN VIAL DATE IS 04/12/2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
382311	METRIX AIR	BLOOD GLUCOSE SYSTEM	NBW	TRIVIDIA HEALTH, INC.	METRIX AIR	MV3212	00021292007720

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 YR