FDA Adverse Event
Injury
Summary report: N
CARE TOUCH
MDR report key: 17342830
·
Received July 18, 2023
Report
- Report Number
- 3016774562-2023-01633
- Event Type
- Injury
- Date Received
- July 18, 2023
- Report Date
- July 18, 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 COMPLAINT: YES MY METER IS READING ABOUT 30 POINTS HIGHER THAN MY ACTUAL BLOOD SUGAR. I WENT TO THE DOCTOR AND HAD MY BLOOD CHECKED AND MY METER SAID 134 AND THE DOCTOR SAID 101. I WAS HOPING TO GET A NEW METER OR MY MONEY BACK."
Description of Event or Problem · 0
CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE. CUSTOMER NOTED THAT THEIR METER WAS READING 30 POINTS HIGHER THAN WHAT THEIR BLOOD SUGAR ACTUALLY WAS. THEY WENT TO THEIR DOCTOR AND CONFIRMED THEIR METER WAS OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2340928 | CARE TOUCH | BLOOD GLUCOSE MONITOR | NBW | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. | CT210 | ||
| 840029 | CARE TOUCH | BLOOD GLUCOSE MONITOR | NBW | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. | CT210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |