FDA Adverse Event
Injury
Summary report: N
FREESTYLE FLASH
MDR report key: 754212
·
Received August 24, 2006
Report
- Report Number
- 2954323-2006-00625
- Event Type
- Injury
- Date Received
- August 24, 2006
- Date of Event
- July 27, 2006
- Report Date
- August 24, 2006
- Manufacturer
- ABBOTT DIABETES CARE INC.
- Product Code
- LFR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER'S METER HAS BEEN REQUESTED FOR INVESTIGATION, SO THE CAUSE OF THE INCIDENT CAN BE IDENTIFIED.
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THE UNIT OF MEASUREMENT SETTING OF THEIR FREESTYLE FLASH CHANGED FROM MMOL/L TO MG/DL. THE CUSTOMER MISTREATED WITH INSULIN BASED ON THE METER READING AND WAS ADMITTED TO THE HOSPITAL. THE CUSTOMER ATE SOME SWEETS TO COUNTERACT THE MEDICAL EVENT, FURTHER DETAILS REGARDING THE CUSTOMER'S TREATMENT IN THE HOSPITAL ARE NOT AVAILABLE. THE CUSTOMER WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE FLASH | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization |