FDA Adverse Event
Injury
Summary report: N
FREESTYLE FREEDOM
MDR report key: 1082246
·
Received July 23, 2008
Report
- Report Number
- 2954323-2008-02309
- Event Type
- Injury
- Date Received
- July 23, 2008
- Date of Event
- June 20, 2008
- Report Date
- July 23, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- LFR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
A NURSE FROM AN ASSISTED LIVING FACILITY REPORTED THAT AFTER RECEIVING A READING OF 167 MG/DL, THE PT WAS GIVEN TWO UNITS OF INSULIN AND LATER DISCOVERED IN BED HAVING SEIZURE. THE PT WAS TREATED BY PARAMEDICS WITH DEXTROSE SOLUTION AND GIVEN SOME FOOD. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE FREEDOM | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA | NI | 0801429 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |