FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1894861
·
Received November 5, 2010
Report
- Report Number
- 2531779-2010-02152
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 7, 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
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED THAT THE PUMP WAS INTERMITTENTLY NOT RESPONDING TO CONTRAST AND DOWN BUTTON PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE/CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. THE DOWN BUTTON CONTACT WAS OBSERVED TO BE MISALIGNED AND THE CONTRAST BUTTON WAS INVERTED. IN ADDITION, THE KEYPAD WAS SWOLLEN.
Description of Event or Problem · 1
THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS NOT ALWAYS RESPONDING TO BUTTON PRESSES. SHE ALSO CLAIMED THAT THE DOWN BUTTON WAS STICKING. THE PT DENIED THAT THE PUMP WAS EXPOSED TO WATER.
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 | 26 YR |