FDA Adverse Event
Injury
Summary report: N
CARE TOUCH
MDR report key: 17406094
·
Received July 27, 2023
Report
- Report Number
- 3016774562-2023-01753
- Event Type
- Injury
- Date Received
- July 27, 2023
- Report Date
- July 27, 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. CUSTOMER DIDN'T RECEIVE ANY ACCURATE READINGS. THE DEVICE WAS GIVING A RANGE OF DIFFERENT READINGS ACROSS MINUTES OF MULTIPLE TESTS.
Description of Event or Problem · 0
CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE . "CUSTOMER REVIEW COMPLAINT: THIS MONITOR IS AWFUL. NOT ACCURATE AT ALL. DON'T WASTE YOUR MONEY. I USUALLY DON'T EVEN LEAVE REVIEWS BUT I HAVE TO WARN YOU ALL IT'S AWFUL. THE SELLER IS NOT HELPFUL. WITHIN TWO MINUTES A READING OF 138 THEN WENT TO 193. IT ALWAYS GIVES ME DIFFERENT READING IN JUST MINUTES OF TAKING IT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756296 | CARE TOUCH | GLUCOSE MONITORING KIT | NBW | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. | CT210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |