FDA Adverse Event
Injury
Summary report: N
FREESTYLE FREEDOM LITE
MDR report key: 1802493
·
Received August 17, 2010
Report
- Report Number
- 2954323-2010-01124
- Event Type
- Injury
- Date Received
- August 17, 2010
- Date of Event
- July 15, 2010
- Report Date
- August 13, 2010
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE METER HAS BEEN RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED.
Description of Event or Problem · 1
A CUSTOMER REPORTED GETTING AN ERROR-2 MESSAGE ON THEIR FREESTYLE FREEDOM LITE METER AND EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA. THE PARAMEDICS WERE CALLED, TREATED CUSTOMER WITH UNSPECIFIED INTRAVENOUS INFUSION AND TRANSPORTED TO A LOCAL HOSPITAL WHERE SHE WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH UNSPECIFIED INTRAVENOUS INFUSION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE FREEDOM LITE | BLOOD GLUCOSE MONITORING SYSTEM | NBW | 1011507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |