FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1202792
·
Received October 15, 2008
Report
- Report Number
- 2531779-2008-00699
- Event Type
- Injury
- Date Received
- October 15, 2008
- Date of Event
- September 14, 2008
- Report Date
- September 14, 2008
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED A COSMETIC SCRATCH ON THE DISPLAY LENS, BUT DEMONSTRATED THAT THE PUMP WAS FUNCTIONING WITHIN REQUIRED SPECIFICATIONS.
Description of Event or Problem · 1
DISTRIBUTOR REPORTS PT REQUIRED GLUCAGON INJECTION, DUE TO LOW BLOOD GLUCOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ANIMAS 2020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |