FDA Adverse Event
Injury
Summary report: N
CARETOUCH
MDR report key: 17306981
·
Received July 12, 2023
Report
- Report Number
- 3016774562-2023-01536
- Event Type
- Injury
- Date Received
- July 12, 2023
- Report Date
- July 12, 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 THE CUSTOMER TESTED THE DEVICE OUT 4 TIMES AND RECEIVED VARYING INACCURATE NUMBERS.
Description of Event or Problem · 0
CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE PRICKED MYSELF 4 TIMES AND GOT DIFFERENT NUMBERS. 107, 83,96,98[?] I MEAN WHAT THE HELL[?].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 771500 | CARETOUCH | BLOOD GLUCOSE MONITOR | NBW | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. | CT210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |