FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1894850
·
Received November 5, 2010
Report
- Report Number
- 2531779-2010-02143
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 6, 2010
- Report Date
- October 7, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED THAT THE PUMP WAS UNRESPONSIVE TO KEYPAD BUTTON PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE/CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. THE BUTTON CONTACTS WERE OBSERVED TO BE MISALIGNED AND INVERTED. IN ADDITION, THE BUTTONS CONTACTS WERE NOT ALWAYS SPRINGING BACK AND THE KEYPAD WAS SWOLLEN.
Description of Event or Problem · 1
THE DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS UNRESPONSIVE TO BUTTON PRESSES.
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 |