FDA Adverse Event
Injury
Summary report: N
PRECISION XTRA/OPTIUM
MDR report key: 1000958
·
Received February 5, 2008
Report
- Report Number
- 2954323-2008-00715
- Event Type
- Injury
- Date Received
- February 5, 2008
- Date of Event
- January 5, 2008
- Report Date
- February 5, 2008
- Manufacturer
- ABBOTT DIABETES CARE LIMITED UK
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
CUSTOMER REPORTED NOT BEING ABLE TO TEST HER BLOOD GLUCOSE DUE TO A DISPLAY ISSUE ON THEIR PRECISION XTRA METER. CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF DIZZINESS, BAD HEADACHE AND "BODY FELT FUNNY". CUSTOMER REPORTED GOING TO ALBERT EINSTEIN HOSP WHERE SHE WAS TREATED WITH INSULIN AND GIVEN A SANDWICH. IT IS UNKNOWN WHAT THE DIAGNOSIS WAS AT THE HOSP, AN INVESTIGATION INTO THE DETAILS OF THIS EVENT IS IN PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION XTRA/OPTIUM | BLOOD GLUCOSE METER | NBW | ABBOTT DIABETES CARE LIMITED UK | NA | 40424 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Hospitalization| R |