FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH BASIC ENHANCED
MDR report key: 429965
·
Received November 20, 2002
Report
- Report Number
- 2939301-2002-11349
- Event Type
- Malfunction
- Date Received
- November 20, 2002
- Report Date
- November 19, 2002
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A PATIENT REPORTED BLOOD GLUCOSE RESULTS OF 59, 109, 199, 180, 193 AND 173 MG/DL WITH A LIFESCAN METER, PERFORMED WITHIN 11-20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN 20% AND/OR LESS THAN 20 MG/DL, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF PRECISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH BASIC ENHANCED | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |