FDA Adverse Event
Injury
Summary report: N
CARETOUCH
MDR report key: 16868653
·
Received May 4, 2023
Report
- Report Number
- 3016774562-2023-01069
- Event Type
- Injury
- Date Received
- May 4, 2023
- Report Date
- May 4, 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 STATED THAT THEY PERFORMED 3 SEPARATE TESTS USING THE CARETOUCH BLOOD GLUCOSE MONITOR KIT AND RECEIVED INACCURATE READINGS EACH TIME.
Description of Event or Problem · 0
CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE. CUSTOMER REVIEW COMPLAINT: "I DID THREE TESTS AT THE SAME TIME, WITH THREE DIFFERENT ANSWERS. ""I DID THREE TESTS AT THE SAME TIME, WITH THREE DIFFERENT ANSWERS. 160/124/137 HOW CAN I TRUST IT? IT SAYS FREE RETURN FOR AMAZON PRIME, BUT IT DOES NOT ALLOW ME TO RETURN IT. JUST WASTE MY MONEY. ONLY THE SUPPLIES ARE STILL USABLE. VERY DISAPPOINTING PURCHASE. ONE PERSON FOUND """.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621176 | CARETOUCH | BLOOD GLUCOSE MONITOR KIT | NBW | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. | CT210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |