FDA Adverse Event
Injury
Summary report: N
PUMP,INSULIN, 512 WW BLUE
MDR report key: 643113
·
Received October 27, 2005
Report
- Report Number
- 2032227-2005-01813
- Event Type
- Injury
- Date Received
- October 27, 2005
- Date of Event
- October 1, 2005
- Report Date
- October 7, 2005
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT HTE CUSTOMER WAS HOSPITALIZED FOR HIGH GLUCOSE LEVEL. TROUBLESHOOTING WAS PERFORMED. THE SELF-TEST PASSED AND NO ANOMALIES FOUND IN MEMORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP,INSULIN, 512 WW BLUE | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-512WWB | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization |