FDA Adverse Event
Injury
Summary report: N
FREESTYLE FLASH
MDR report key: 1161241
·
Received September 10, 2008
Report
- Report Number
- 2954323-2008-02531
- Event Type
- Injury
- Date Received
- September 10, 2008
- Date of Event
- August 3, 2008
- Report Date
- September 10, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- LFR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
CUSTOMER'S MOTHER REPORTED CUSTOMER RECEIVED LOW GLUCOSE READING (69 MG/DL) FROM THEIR FREESTYLE FLASH METER. CUSTOMER'S MOTHER REPORTED CUSTOMER EXPERIENCED SYMPTOMS OF THIRST, VOMITING, WEIGHT LOSS AND "SICK WITH KETONES". CUSTOMER WAS BROUGHT TO YALE NEW HAVEN HOSPITAL WHERE SHE WAS BEING DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH "ANTI-NAUSEA" MEDICATION, INTRAVENOUS SOLUTION AND ADJUSTMENT ON HER INSULIN MEDICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE FLASH | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |