FDA Adverse Event
Other
Summary report: N
ONE TOUCH BASIC
MDR report key: 377899
·
Received January 31, 2002
Report
- Report Number
- 2939301-2002-01244
- Event Type
- Other
- Date Received
- January 31, 2002
- Report Date
- November 13, 2001
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
METER NAME: ONE TOUCH BASIC ENHANCED. STRIP NAME: UNKNOWN. METER CODE: UNKNOWN. STRIP CODE: UNKNOWN. STRIP CODE: UNKNOWN. STRIP STORAGE: UNKNOWN. SYMPTOMS: NONE. A PATIENT REPORTED THEY WERE HOSPITALIZED. THEIR METER WAS SHOWING BATTERY ICON. THE RESULT ON THEIR METER WAS UNKNOWN. THE RESULT ON THE HOSPITAL METER WAS 679. THE TIME DIFFERECE BETWEEN PATIENT'S METER AND HOSPITAL METER WAS UNKNOWN. TREATMENT WAS UNKNOWN. NO FURTHER INFORMATION HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH BASIC | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Hospitalization |