FDA Adverse Event
Other
Summary report: N
ONE TOUCH II
MDR report key: 375695
·
Received January 30, 2002
Report
- Report Number
- 2939301-2002-00991
- Event Type
- Other
- Date Received
- January 30, 2002
- Report Date
- October 4, 2001
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
METER NAME: ONE TOUCH II. STRIP NAME: UNK. METER CODE: UNK. STRIP CODE: UNK. STRIP STORAGE: UNK. SYMPTOMS: NO SYMPTOMS. A PT FAMILY MEMBER REPORTED PT WAS TAKEN TO THE DOCTOR. PT'S METER ALLEGEDLY WOULD NOT TURN ON. THE RESULT ON THEIR METER WAS UNABLE TO TEST. THE RESULT ON THE DR'S METER WAS 400MG/DL. TREATMENT WAS INSULIN AT THE DR'S OFFICE. NO FURTHER INFO 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 | 88 YR | Other |