FDA Adverse Event
Other
Summary report: N
ONE TOUCH II
MDR report key: 383069
·
Received January 30, 2002
Report
- Report Number
- 2939301-2002-00945
- Event Type
- Other
- Date Received
- January 30, 2002
- Report Date
- December 3, 2001
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
METER NAME: OT II, STRIP NAME: LIFESCAN ONE TOUCH, METER CODE: UNKNOWN, STRIP CODE: UNKNOWN, STRIP STORAGE: UNKNOWN, SYMPTOMS: SHADY, WEAK. A PATIENT REPORTED THEY WERE UNABLE TO TEST. THEIR METER ALLEGEDLY WOULD ONLY PROMPT ERROR 2 AND C BEFORE READINGS. THERE WAS NO RESULT ON THEIR METER. THERE WERE NO OTHER TESTS OR COMPARISONS. NOT TREATED. NO FURTHER INFORMATION HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH II | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other |