FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1882720
·
Received October 21, 2010
Report
- Report Number
- 2531779-2010-01815
- Event Type
- Malfunction
- Date Received
- October 21, 2010
- Date of Event
- September 22, 2010
- Report Date
- September 22, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE PUMP WAS INTERMITTENTLY RESPONDING TO THE DOWN ARROW BUTTON AND THERE WAS ADHESIVE/CONTAMINATION FOUND UNDER THE BUTTON CONTACTS.
Description of Event or Problem · 1
THE PT CLAIMED THAT THE PUMP IS NOT RESPONDING TO THE DOWN ARROW BUTTON. THE PUMP REPORTEDLY HAS NOT BEEN EXPOSED TO MOISTURE AND THE RUBBER KEYPAD IS INTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ANIMAS 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |