FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH BASIC
MDR report key: 411166
·
Received August 12, 2002
Report
- Report Number
- 2939301-2002-08760
- Event Type
- Malfunction
- Date Received
- August 12, 2002
- Report Date
- August 8, 2002
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A PATIENT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A LIFESCAN METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 160, 107 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 35%. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFORMATION.
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 | UNKNOWN |