FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE LITE
MDR report key: 1355582
·
Received February 25, 2009
Report
- Report Number
- 2954323-2009-00220
- Event Type
- Malfunction
- Date Received
- February 25, 2009
- Date of Event
- January 27, 2009
- Report Date
- February 25, 2009
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE LITE BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 120, 199, 20, 97, 132 AND 72 MG/DL WITHIN 10 MINS. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO A "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE LITE | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA | NI | 0827334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |