FDA Adverse Event
Injury
Summary report: N
PRECISION XTRA/OPTIUM
MDR report key: 1133028
·
Received August 20, 2008
Report
- Report Number
- 2954323-2008-02432
- Event Type
- Injury
- Date Received
- August 20, 2008
- Date of Event
- July 22, 2008
- Report Date
- August 20, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS RELATED TO A DELIVERY ISSUE. NO PRODUCT IS EXPECTED BACK FOR INVESTIGATION. THIS IS A FINAL REPORT.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT DUE TO THE LACK OF DELIVERY OF A REPLACEMENT METER, HE WAS UNABLE TO TEST. AS A RESULT, HE EXPERIENCED HIGH BLOOD GLUCOSE, SHORTNESS OF BREATH AND LOST CONSCIOUSNESS. HE REPORTED BEING SEEN AT A LOCAL HOSPITAL, DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION XTRA/OPTIUM | BLOOD GLUCOSE MONITORING SYSTEM | NBW | ABBOTT DIABETES CARE INC, USA | NI | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |