FDA Adverse Event
Injury
Summary report: N
CARE TOUCH
MDR report key: 17556368
·
Received August 16, 2023
Report
- Report Number
- 3016774562-2023-01860
- Event Type
- Injury
- Date Received
- August 16, 2023
- Report Date
- August 16, 2023
- Manufacturer
- TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE. INCORRECT READINGS ON THE METER CAUSE THE CUSTOMER'S DAUGHTER TO GO TO THE EMERGENCY ROOM.
Description of Event or Problem · 0
CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE "CUSTOMER COMPLAINT: THIS METER CAUSED MY DAUGHTER TO GO TO THE EMERGENCY ROOM. IT HAS BEEN VERY INCONSISTENT WITH ITS READINGS. TONIGHT IT READ 555 SO WE TOOK HER IMMEDIATELY TO THE ER. IT WAS 267 AT THE HOSPITAL. THE OTHER DAY IT READ 59 SO I GAVE HE A GLUCOSE TIME AND WE CHECKED WITH ANOTHER MACHINE AND SHE WAS ACTUAL 196 SO THE GLUCOSE TAB MADE HER RISE TO OVER 300. DIABETES IS A LIFE AND DEATH DISEASE AND THIS MACHINE IS UNRELIABLE. THAT IS NOT ACCEPTABLE FOR THE PRODUCTS PURPOSE. I WANT A REFUND SO I CAN BUY ONE TO RELIABLE CHECK MY DAUGHTER'S BLOOD SUGARS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458713 | CARE TOUCH | BLOOD GLUCOSE MONITOR | NBW | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. | CT210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |