FDA Adverse Event
Injury
Summary report: N
FREESTYLE
MDR report key: 1030259
·
Received April 17, 2008
Report
- Report Number
- 2954323-2008-01499
- Event Type
- Injury
- Date Received
- April 17, 2008
- Date of Event
- March 18, 2008
- Report Date
- April 17, 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 REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.
Description of Event or Problem · 1
A CUSTOMER REPORTED HER FREESTYLE BLOOD GLUCOSE METER WAS NOT WORKING OVER THE LAST MONTH AND BECAUSE OF THAT ISSUE, SHE COULD NOT PERFORM HER BLOOD GLUCOSE TEST. SHE REPORTED EXPERIENCING THE FOLLOWING SYMPTOMS: VOMITING, DIARRHEA AND LIGHTHEADEDNESS. ALTHOUGH THE CUSTOMER REPORTED BEING DIAGNOSED AND TREATED FOR SEVERE HYPOGLYCEMIA, THE TREATMENT FOR THE HYPOGLYCEMIC EVENT WAS REPORTEDLY INSULIN AND AN INTRAVENOUS SOLUTION. ADDITIONALLY, THE CUSTOMER REPORTED EATING FOOD AT THE HOSPITAL TO INCREASE HER BLOOD GLUCOSE. 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 | 0722614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Hospitalization| R |