FDA Adverse Event Malfunction Summary report: N

TRUEMETRIX

MDR report key: 7673325 · Received July 10, 2018

Report

Report Number: 1000113657-2018-00739
Event Type: Malfunction
Date Received: July 10, 2018
Date of Event: June 14, 2018
Report Date: July 10, 2018
Manufacturer: TRIVIDIA HEALTH, INC.
Product Code: NBW
UDI-DI: 00021292006075
PMA / PMN Number: K140100
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. TEST STRIP UDI# (B)(4). MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER 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 165, 172, 204 AND 162 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 120 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. CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/18/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
518073	TRUEMETRIX	BLOOD GLUCOSE SYSTEM	NBW	TRIVIDIA HEALTH, INC.	TRUEMETRIX	MU2323	00021292006075

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 YR			SECOND THERAPY