FDA Adverse Event
Injury
Summary report: N
PRECISION XTRA/ OPTIUM
MDR report key: 875093
·
Received June 28, 2007
Report
- Report Number
- 2954323-2007-11486
- Event Type
- Injury
- Date Received
- June 28, 2007
- Date of Event
- May 29, 2007
- Report Date
- June 28, 2007
- Manufacturer
- ABBOTT DIABETES CAE LIMITED UK
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED AND ACCORDING TO OUR INVESTIGATION THE COMPLAINT IS NOT CONFIRMED. ERRORS DURING CALIBRATION WERE NOT OBSERVED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED AN ERROR MESSAGE ON THEIR PRECISION XTRA BLOOD GLUCOSE MONITOR. ADDITIONALLY, THE CUSTOMER STATED SHE EXPERIENCED CHEST PAIN, BLURRED VISION, HEADACHES, AND WAS TREATED AT THE HOSPITAL. HOWEVER, IT IS UNK WHETHER THE MEDICAL EVENT HAPPENED AT THE SAME TIME AS THE ERROR MESSAGE, SINCE THE CUSTOMER INDICATES THAT THE MEDICAL EVENT HAPPENED 3 WEEKS AGO. THERE WAS NO DIAGNOSIS AVAILABLE OR REPORT OF DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION XTRA/ OPTIUM | BLOOD GLUCOSE METER | NBW | ABBOTT DIABETES CAE LIMITED UK | NA | 41432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |