FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PROFILE
MDR report key: 456331
·
Received April 22, 2003
Report
- Report Number
- 2939301-2003-02918
- Event Type
- Malfunction
- Date Received
- April 22, 2003
- Report Date
- April 17, 2003
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A PT REPORTED BLOOD GLUCOSE RESULTS OF 140, 207, 120, 156 MG/DL AND 103 MG/DL WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/OR <=20 MG/DL, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN THE TERMS OF PRECISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PROFILE | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |