FDA Adverse Event Malfunction Summary report: N

TRUETRACK

MDR report key: 8861760 · Received August 5, 2019

Report

Report Number: 1000113657-2019-00790
Event Type: Malfunction
Date Received: August 5, 2019
Date of Event: July 11, 2019
Report Date: August 5, 2019
Manufacturer: TRIVIDIA HEALTH, INC.
Product Code: NBW
UDI-DI: 00021292007638
PMA / PMN Number: K032657
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INTERNAL REPORT # (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-62: USER HAD POOR TECHNIQUE. TEST STRIPS UDI: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

Description of Event or Problem · 1

CONSUMER REPORTED COMPLAINT FOR ERRATIC AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 171, 141 AND 285 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 140 MG/DL. CUSTOMER HAS BEEN USING THE METER SINCE THE END OF MAY. CUSTOMER WAS NOT USING THE CORRECT TESTING TECHNIQUE. 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 BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2021 AND TEST STRIPS WERE OPENED THE END OF MAY 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
656142	TRUETRACK	BLOOD GLUCOSE SYSTEM	NBW	TRIVIDIA HEALTH, INC.	TRUETRACK	RW5333	00021292007638

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 YR