FDA Adverse Event
Injury
Summary report: N
FREESTYLE FLASH
MDR report key: 1060681
·
Received June 13, 2008
Report
- Report Number
- 2954323-2008-02098
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 12, 2008
- Report Date
- June 13, 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 ONCE INVESTIGATION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
CUSTOMER'S MOTHER REPORTED CUSTOMER WAS NOT ABLE TO GET RESULTS ON HER FREESTYLE FLASH BLOOD GLUCOSE MONITOR AND BECAUSE OF THIS SHE TOOK TOO MUCH MEDICATION, WHICH RESULTED IN THE CUSTOMER EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA. CUSTOMER WAS TRANSPORTED TO MOUNT SINAI HOSPITAL WHERE SHE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA. SHE WAS GIVEN GLUCOSE, INTRAVENOUS FLUIDS AND LANTUS TO STABILIZE HER GLUCOSE LEVEL. 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 FLASH | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA | NI | 0721926 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention| S |