FDA Adverse Event
Injury
Summary report: N
MINIMED INFUSION PUMP
MDR report key: 495233
·
Received November 13, 2003
Report
- Report Number
- 2032227-2003-01202
- Event Type
- Injury
- Date Received
- November 13, 2003
- Date of Event
- October 19, 2003
- Report Date
- October 19, 2003
- Manufacturer
- MINIMED INC.
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE FAMILY MEMBER CALLED TO REPORT THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD SUGAR LEVELS. IT WAS INDICATED THAT THE CUSTOMER HAD BEEN FOLLOWING THE TWO HBG RULE. AFTER REMOVING THE PUMP, THE FAMILY MEMBER STATED THAT THE CUSTOMER TREATED HBG WITH A MANUAL INJECTION WHICH BROUGHT CUSTOMER'S BGS DOWN. IT WAS REPORTED THAT THE CUSTOMER WAS NOT SPILLING KETONES AT THAT TIME. THE PROGRAMMING ON THE PUMP WAS ACCURATE AND IT PASSED THE FUNCTIONAL TESTS.
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 | 10 YR | Hospitalization |