FDA Adverse Event
Other
Summary report: N
ONE TOUCH PROFILE
MDR report key: 377819
·
Received January 30, 2002
Report
- Report Number
- 2939301-2002-00979
- Event Type
- Other
- Date Received
- January 30, 2002
- Report Date
- December 11, 2001
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
METER NAME: OT PROFILE. STRIP NAME: ONE TOUCH. METER CODE: UNKNOWN. STRIP CODE: UNKNOWN. STRIP STORAGE: UNKNOWN. SYMPTOMS: DIZZY AND SICKNESS. A PATIENT REPORTED THEY WERE OBTAINING INACCURATELY HIGH READING AND WENT TO DOCTOR. THEIR METER ALLEGEDLY WAS INACCURRATELY HIGH. THE RESULT ON THEIR METER WAS 224 MG/DL. THE RESULT ON THE DOCTOR'S METER WAS UNKNOWN. THE TIME DIFFERENCE BETWEEN PATIENT'S METER AND THE DOCTOR'S WAS UNKNOWN. NO TREATMENT. DOCTOR CHANGE PATIENT'S MEDICATION. NO FURTHER INFORMATION HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PROFILE | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |