FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1881521
·
Received October 19, 2010
Report
- Report Number
- 2531779-2010-01745
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Date of Event
- September 20, 2010
- Report Date
- September 20, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED THAT THE PUMP WAS INTERMITTENTLY UNRESPONSIVE TO UP AND DOWN ARROW BUTTON PRESSES. THE UP AND DOWN ARROW BUTTON CONTACTS WERE OBSERVED TO BE MISALIGNED.
Description of Event or Problem · 1
THE REPORTER CONTACTED ANIMAS ON BEHALF OF THE PT (HER DAUGHTER) ALLEGED THAT THE PUMP WAS UNRESPONSIVE TO KEYPAD BUTTON PRESSES. THE REPORTER CLAIMED THAT SHE HAD TO PRESS THE UP AND DOWN ARROW BUTTONS HARD AND SEVERAL TIMES IN ORDER FOR THE PUMP TO RESPOND. THE REPORTER ALSO CLAIMED THAT THE PUMP WAS RESPONDING INTERMITTENTLY TO OK BUTTON PRESSES. SHE ALSO ALLEGED THAT THE BUTTONS WOULD NOT CLICK OR SPRING BACK AS USUAL. THE REPORTER DENIED THAT THE DEVICE 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 | 14 YR |