FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH BASIC
MDR report key: 413326
·
Received August 21, 2002
Report
- Report Number
- 2939301-2002-09002
- Event Type
- Malfunction
- Date Received
- August 21, 2002
- Report Date
- August 16, 2002
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER CALLED LFS ION 08/2002 ALLEGING THE OT BASIC METER WAS MISSING SEGMENTS FROM THE DISPLAY. THE ISSUE WAS UNRESOLVED WITH TROUBLESHOOTING. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF DIZZINESS, TREMBLING, AND FEELING TERRIBLE. TREATED SELF WITH ORANGE JUICE AND FELT BETTER AFTERWARDS. THE METER HAS BEEN REPLACED FOR THE CUSTOMER.
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 | 72 YR |