FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH ULTRA
MDR report key: 579995
·
Received February 4, 2004
Report
- Report Number
- 2939301-2004-00768
- Event Type
- Malfunction
- Date Received
- February 4, 2004
- Report Date
- January 31, 2004
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A PATIENT REPORTED BLOOD GLUCOSE RESULT OF "180, 166 AND 241 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH ULTRA | GLUCOSE MONITORING SYS/KIT | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |