FDA Adverse Event
Injury
Summary report: N
CARETOUCH
MDR report key: 17306645
·
Received July 12, 2023
Report
- Report Number
- 3016774562-2023-01484
- 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 NOT WORKING CORRECTLY / INACCURATE RESULTS.
Description of Event or Problem · 0
CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE NOT WORKING CORRECTLY / INACCURATE RESULTS. THE GLUCOMETER WAS USED 4 TIMES A DAY TO CHECK MY SUGAR LEVELS AND EACH TIME WAS GIVING READINGS HI OR 450 AND MORE EACH TIME. AND I WAS MEDICATING ACCORDING TO THOSE NUMBERS. IT TURNS OUT THESE READINGS FOR THE PAST MONTH WERE INCORRECT AND WAS REGULARLY CAUSING ME TO OVERDOSE ON MY MEDICATION. PURCHASED 1.5 YEARS AGO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 748264 | CARETOUCH | BLOOD GLUCOSE MONITOR | NBW | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. | CT210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |