FDA Adverse Event
Injury
Summary report: N
FREESTYLE FREEDOM LITE
MDR report key: 2160865
·
Received July 13, 2011
Report
- Report Number
- 2954323-2011-03844
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- June 17, 2011
- Report Date
- July 11, 2011
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
A CUSTOMER REPORTED THE TEST WOULD NOT START AFTER A SAMPLE WAS APPLIED USING A FREESTYLE FREEDOM LITE METER. THE CUSTOMER STATED THAT ON (B)(6) 2011 AROUND 11AM THE CUSTOMER WAS UNABLE TO TEST AND EXPERIENCED SYMPTOMS OF DIAPHORESIS, HEADACHE, CONFUSION, FATIGUE, NAUSEA AND "PASSED OUT". THE CUSTOMER REPORTED A LOSS OF CONSCIOUSNESS, ALTHOUGH SHE DID NOT SEEK MEDICAL ATTENTION FOR THIS EVENT. NO SELF-TREATMENT WAS REPORTED. THERE IS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE FREEDOM LITE | BLOOD GLUCOSE MONITORING SYSTEM | NBW | 1107301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |