FDA Adverse Event
Injury
Summary report: N
FREESTYLE
MDR report key: 1000068
·
Received February 15, 2008
Report
- Report Number
- 2954323-2008-00832
- Event Type
- Injury
- Date Received
- February 15, 2008
- Date of Event
- January 14, 2008
- Report Date
- February 15, 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
THE CUSTOMER'S PRODUCT HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.
Description of Event or Problem · 1
A CUSTOMER REPORTED BEING UNABLE TO GET A READING FROM HIS FREESTYLE BLOOD GLUCOSE METER. HE REPORTED EXPERIENCING THE FOLLOWING SYMPTOMS: DISORIENTED, LETHARGIC AND PROFUSELY SWEATING. THE PARAMEDICS WERE CALLED, CHECKED CUSTOMER'S BLOOD GLUCOSE, OBTAINED A READING OF 29 MG/DL AND ADMINISTERED AN INTRAVENOUS DEXTROSE SOLUTION. HE WAS TRANSPORTED TO THE HOSPITAL WHERE HE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA, AND CONTINUED THE TREATMENT WITH DEXTROSE INTRAVENOUSLY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA | NA | 0710115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA YR | Hospitalization| R |