FDA Adverse Event
Injury
Summary report: N
CARE TOUCH
MDR report key: 17556098
·
Received August 16, 2023
Report
- Report Number
- 3016774562-2023-01829
- 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 HI THE METER READINGS ARE NOT CORRECT. CAN YOU PLEASE HELP ME WITH RETURNING THIS AND REFUND. I TRIED TESTING IN THE MORNING WITH FASTING. IT'S SHOWS 3 DIFFERENT NUMBERS LIKE 127,104 AND 92 FOR 3 CONSECUTIVE TESTS TAKEN IMMEDIATELY.
Description of Event or Problem · 0
CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE . CUSTOMER NOTED THAT THE METER'S READING WERE INCORRECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458682 | CARE TOUCH | BLOOD GLUCOSE MONITOR | NBW | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. | CT210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |