FDA Adverse Event
Malfunction
Summary report: N
FASTTAKE
MDR report key: 556705
·
Received April 30, 2004
Report
- Report Number
- 2939301-2004-02794
- Event Type
- Malfunction
- Date Received
- April 30, 2004
- Report Date
- April 27, 2004
- 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 11.8 MMO/L WITH A LIFESCAN METER AND 8.7 MMO/L ON A 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 THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF ACCURACY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FASTTAKE | GLUCOSE MONITORING SYS/KIT | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |