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 |