FDA Adverse Event
Injury
Summary report: N
PRECISION XTRA/OPTIUM
MDR report key: 1062937
·
Received June 19, 2008
Report
- Report Number
- 2954323-2008-02133
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- April 12, 2008
- Report Date
- June 19, 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 THEIR PRECISION XTRA METER WAS NOT WORKING BECAUSE THE CALIBRATOR AND BLISTER PACK WERE MISSING. CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF LIGHTHEADEDNESS, ITCHINESS, SWEATINESS AND WEAKNESS. CUSTOMER REPORTED GOING TO THE HOSP WHERE SHE WAS DIAGNOSED WITH SEVERE HYPERGLYCEMIA AND TREATED WITH AN ANTIBIOTIC AND GLUCOSE. IT IS UNK IF CUSTOMER ALSO HAS ANY OTHER UNDERLYING DISEASE WHICH REQUIRED ANTIBIOTICS TREATMENT. IN ADDITION, THE GLUCOSE TREATMENT IS INCONSISTENT WITH HER DIAGNOSIS, AN INVESTIGATION INTO THE DETAILS 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 | 42704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |