FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH ULTRA
MDR report key: 379673
·
Received February 4, 2002
Report
- Report Number
- 2939301-2002-01022
- Event Type
- Malfunction
- Date Received
- February 4, 2002
- Report Date
- November 19, 2001
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
METER NAME: ULTRA. STRIP NAME: ULTRA STRIPS. METER CODE: UNKNOWN. STRIP CODE: UNKNOWN. STRIP STORAGE: UNKNOWN. SYMPTOMS: STATED LOW/HIGH BLOOD SUGAR SYMPTOMS. A PATIENT REPORTED THAT METER JUST DOES NOT WORK. THEIR METER ALLEGEDLY HAD INCORRECT MEMORY. THE RESULT ON THEIR METER WAS 132, 140, 130. TREATMENT WAS DRANK ORANGE JUICE, EXERCISED, AND DOCTOR CHANGED MEDICINE. 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 | 46 YR | Required Intervention |