FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH BASIC ENHANCED
MDR report key: 412750
·
Received August 20, 2002
Report
- Report Number
- 2939301-2002-08902
- Event Type
- Malfunction
- Date Received
- August 20, 2002
- Report Date
- August 15, 2002
- Manufacturer
- LIFESCAN, INC
- Product Code
- CFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A PT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A LIFESCAN METER. THE PT'S BLOOD GLUCOSE RESULTS WERE 230, 121, 134, 143 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 34%. PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED.
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 | 64 YR |