FDA Adverse Event
Other
Summary report: N
ONE TOUCH ULTRA
MDR report key: 377864
·
Received January 31, 2002
Report
- Report Number
- 2939301-2002-01204
- Event Type
- Other
- Date Received
- January 31, 2002
- Report Date
- January 2, 2002
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
METER NAME: ONE TOUCH ULTRA. STRIP NAME: LIFESCAN. METER CODE: UNKNOWN, STRIP CODE: UNKNOWN. STRIP STORAGE: UNKNOWN. SYMPTOMS: NO SYMPTOMS. A PATIENT REPORTED THEY WERE UNABLE TO OBTAIN ANY BLOOD GLUCOSE RESULT AND WAS SEEN IN ER. THEIR METER ALLEGEDLY WOULD ONLY PROMPT ERROR 1 MESSAGE. PATIENT WAS NOT TREATED. NO FURTHER INFORMATION HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH ULTRA | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization |