FDA Adverse Event
Malfunction
Summary report: N
FASTTAKE
MDR report key: 442630
·
Received February 7, 2003
Report
- Report Number
- 2939301-2003-01098
- Event Type
- Malfunction
- Date Received
- February 7, 2003
- Report Date
- January 28, 2003
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A PT REPORTED BLOOD GLUCOSE RESULTS OF "134 MG/DL" WITH A LIFESCAN METER AND "87 MG/DL" ON LABORATORY DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF ACCURACY. A CONTROL SOLUTION TEST PERFORMED ONE WEEK PRIOR FELL WITHIN RANGE (146 MG/DL/130-191 MG/DL).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FASTTAKE | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |