FDA Adverse Event
Injury
Summary report: N
PUMP, US, 50, INULSIN, 508, BLUE
MDR report key: 574323
·
Received February 18, 2005
Report
- Report Number
- 2032227-2005-00120
- Event Type
- Injury
- Date Received
- February 18, 2005
- Date of Event
- January 29, 2005
- Report Date
- January 29, 2005
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CUSTOMER WAS HOSPITALIZED FOR HIGH BGS AND DKA. THE CUSTOMER OFTEN HAS DKA AND PT IS BRITTLE DIABETIC. IN ADDITION, IT WAS STATED THAT CUSTOMER WAS HOSPITALIZED BEFORE AND THE DIABETES MANAGEMENT CONSULTANT WAS NOTIFIED. FURTHERMORE THE CUSTOMER WENT BACK IN THE HOSPITAL WITH DKA AGAIN. THE CUSTOMER WAS NOT FEELING WELL TO TROUBLESHOOT THE DEVICE AT THE TIME OF CALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP, US, 50, INULSIN, 508, BLUE | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-508UB | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Hospitalization |