FDA Adverse Event
Injury
Summary report: N
FREESTYLE FLASH
MDR report key: 1040451
·
Received May 8, 2008
Report
- Report Number
- 2954323-2008-01762
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- April 8, 2008
- Report Date
- May 8, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC. USA
- Product Code
- LFR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NO INFORMATION
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
CUSTOMER REPORTED THAT DUE TO RECEIVING AN ERROR MESSAGE ON HER METER, SHE WAS UNABLE TO TEST AND EXPERIENCED SYMPTOMS OF DIZZINESS, SHAKINESS, AND WAS "MENTALLY NOT HERSELF". THE PARAMEDICS WERE CALLED AND TREATED HER WITH INSULIN. SHE WAS TRANSPORTED TO A LOCAL HOSPITAL, DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH ADDITIONAL INSULIN. 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 | 0620834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |