FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1041170
·
Received May 12, 2008
Report
- Report Number
- 2531779-2008-00251
- Event Type
- Injury
- Date Received
- May 12, 2008
- Date of Event
- April 9, 2008
- Report Date
- April 9, 2008
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. UPON RECEIPT AT ANIMAS, THE PUMP WAS FOUND TO HAVE A DAMAGED FORCE SENSOR WHICH RENDERED IT INOPERABLE AS IT COULD NO LONGER BE PRIMED. THE PUMP HISTORY INDICATED THAT THE PUMP WAS IN USE ON THE DATE OF THE HOSPITALIZATION, AND INSULIN DELIVERY WAS CONSISTENT WITH THE PATIENT'S PROGRAMMED DOSAGES.
Description of Event or Problem · 1
THE PATIENT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS AND DKA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | IR 1200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |