FDA Adverse Event
Injury
Summary report: N
MEDISENSE OPTIUM
MDR report key: 1023402
·
Received April 2, 2008
Report
- Report Number
- 2954323-2008-01292
- Event Type
- Injury
- Date Received
- April 2, 2008
- Date of Event
- February 18, 2008
- Report Date
- April 2, 2008
- Manufacturer
- ABBOTT DIABETES CARE LIMITED UK
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT DID NOT INVOLVE A PRODUCT MALFUNCTION AND THEREFORE, NO PRODUCT INVESTIGATION IS REQUIRED. THE CUSTOMER REPORTED RECEIVING THE NEW PRODUCT AND FEELING WELL. THIS IS THE FINAL REPORT.
Description of Event or Problem · 1
A CUSTOMER REPORTED NOT RECEIVING HER MEDISENSE BLOOD GLUCOSE METER AND EXPERIENCING THE FOLLOWING SYMPTOMS: VOMITING, FEVER, CHILLS AND LOWER ABDOMEN PAIN. SHE ALSO REPORTED HAVING A METER READING OF 600 MG/DL, BUT IT IS UNCLEAR WHAT DEVICE WAS USED TO OBTAIN THAT READING. ALTHOUGH THE CUSTOMER REPORTED BEING TREATED WITH INSULIN AT THE HOSP, IT IS UNCLEAR THE MEDICAL DIAGNOSIS AS THE CUSTOMER STATED THE INSULIN WAS GIVEN AS A TREATMENT FOR SEVERE HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDISENSE OPTIUM | BLOOD GLUCOSE METER | NBW | ABBOTT DIABETES CARE LIMITED UK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Hospitalization| R |