FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1904204
·
Received November 15, 2010
Report
- Report Number
- 2531779-2010-02292
- Event Type
- Malfunction
- Date Received
- November 15, 2010
- Date of Event
- October 15, 2010
- Report Date
- October 15, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT YET BEEN COMPLETED. WHEN EVAL IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
THE PT REPORTED THAT THE OK AND DOWN ARROW BUTTONS WERE NOT RESPONDING OR OVER-RESPONDING ON THE KEYPAD. THE REPORTER DENIES DAMAGE TO THE KEYPAD OR EXPOSURE TO WATER AND CLEANING PRODUCTS. THE BUTTONS STILL SPRING BACK AND THE UP ARROW BUTTON WAS REPORTED TO BE WORKING APPROPRIATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | IR 1250 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |