FDA Adverse Event
Injury
Summary report: N
FREESTYLE FREEDOM
MDR report key: 1190349
·
Received October 6, 2008
Report
- Report Number
- 2954323-2008-02681
- Event Type
- Injury
- Date Received
- October 6, 2008
- Date of Event
- September 10, 2008
- Report Date
- October 6, 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
THIS IS AN FINAL REPORT. THIS CASE INVOLVES A DELIVERY ISSUE, NO PRODUCT IS EXPECTED BACK FOR INVESTIGATION.
Description of Event or Problem · 1
CUSTOMER'S DAUGHTER REPORTED THAT DUE TO A DELIVERY ISSUE WITH THEIR MOTHER'S TEST STRIPS, SHE WAS UNABLE TO TEST AND EXPERIENCED BLURRY VISION, SHAKINESS AND NUMBNESS IN HER TOES. SHE ALSO REPORTED HER MOTHER LOST CONSCIOUSNESS. IT IS UNCLEAR IF THE LOSS OF CONSCIOUSNESS OCCURRED DURING THE SAME EVENT. THEY REPORTED BEING SEEN AT A LOCAL HOSPITAL, DIAGNOSED WITH HYPERGLYCEMIA, HOWEVER, THEY REPORTED BEING TREATED WITH METFORMIN AND NON-DIABETIC RELATED MEDICATION WHICH IS INCONSISTENT WITH THE DIAGNOSIS. 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 FREEDOM | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA. | NI | 0717140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |