FDA Adverse Event
Other
Summary report: N
ONE TOUCH BASIC
MDR report key: 378373
·
Received February 1, 2002
Report
- Report Number
- 2939301-2002-01444
- Event Type
- Other
- Date Received
- February 1, 2002
- Report Date
- November 12, 2001
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
METER NAME: BASIC. STRIP NAME: ONE TOUCH. METER CODE: UNKNOWN. STRIP CODE: UNKNOWN. SYMPTOMS: NONE. A PT REPORTED THE DR HAD TO ADJUST MEDICATION BECAUSE METER WAS NOT RELIABLE DUE TO THE FLICKERING NUMBERS. THEIR METER ALLEGEDLY WOULD FLICKER NUMBERS BACK AND FORTH FROM 96 TO 95. THE RESULT ON THEIR METER WAS 96. THE RESULT ON THE, INCREASED GLUCOPHAGE. THE TIME DIFFERENCE BETWEEN PT'S METER AND, NO COMPARISON. TREATMENT WAS NOT TREATED. NO FURTHER INFO HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH BASIC | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other |