FDA Adverse Event
Injury
Summary report: N
PRECISION XTRA/OPTIUM
MDR report key: 1152827
·
Received September 4, 2008
Report
- Report Number
- 2954323-2008-02493
- Event Type
- Injury
- Date Received
- September 4, 2008
- Date of Event
- August 2, 2008
- Report Date
- September 4, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- 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 PROD HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
CUSTOMER'S WIFE REPORTED A DISPLAY ISSUE WITH THEIR PRECISION XTRA METER WITH TWO EPISODES OF FINDING CUSTOMER LYING IN BED UNRESPONSIVELY. IN ADDITION, THE CUSTOMER'S WIFE REPORTED CUSTOMER WAS "NOT ABLE TO MOVE AND SHAKING UNCONTROLLABLY". FOR BOTH OCCASIONS, THE PARAMEDICS WERE CALLED AND TRANSPORTED THE CUSTOMER TO A LOCAL HOSP WHERE HE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND BEING TREATED WITH INTRAVENOUS SOLUTION. IN THE OTHER OCCASION, CUSTOMER'S WIFE REPORTED THE CUSTOMER WAS DIAGNOSED WITH PNEUMONIA AT THE HOSP WITH UNK TREATMENT.
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 | NA | 43132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |