FDA Adverse Event
Injury
Summary report: N
MINIMED INFUSION PUMP
MDR report key: 499964
·
Received December 10, 2003
Report
- Report Number
- 2032227-2003-01358
- Event Type
- Injury
- Date Received
- December 10, 2003
- Date of Event
- November 12, 2003
- Report Date
- November 12, 2003
- Manufacturer
- MINIMED INC.
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER WAS TAKEN TO THE HOSP FOR HIGH BLOOD SUGAR LEVELS. THE SPOUSE WAS UNSURE IF THE CUSTOMER WAS RESPONDING TO THE MANUAL INJECTIONS. IT WAS INDICATED THAT THE CUSTOMER WAS NOT ADMITTED, BUT WILL BE AT THE HOSP FOR A FEW MORE HOURS. THE SPOUSE WANTED THE STATUS OF THE REPLACEMENT PUMP THAT WAS SHIPPED OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINIMED INFUSION PUMP | INFUSION PUMP | LZG | MINIMED INC. | MMT-511NAC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Hospitalization |