FDA Adverse Event Malfunction Summary report: N

EASY TOUCH

MDR report key: 7679959 · Received July 11, 2018

Report

Report Number
3005798905-2018-00674
Event Type
Malfunction
Date Received
July 11, 2018
Date of Event
June 11, 2018
Report Date
July 11, 2018
Manufacturer
MHC MEDICAL PRODCUTS, LLC.
Product Code
NBW
PMA / PMN Number
K073592
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

EMAIL MESSAGES: A CUSTOMER RETURNED HIS GNP EASY TOUCH SYSTEM BECAUSE IT QUIT WORKING AFTER A WEEK. IT LOOKS AS IF THE BATTERY CORRODED, HE PUT A NEW BATTERY IN, IT STILL DOES NOT WORK. WHAT SHOULD WE DO? PLEASE LET US KNOW.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
520966 EASY TOUCH GLUCOSE MONITOR SYSTEM NBW MHC MEDICAL PRODCUTS, LLC.

Patients

Seq Age Sex Outcome Treatment
1