FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1925952
·
Received November 24, 2010
Report
- Report Number
- 2531779-2010-02473
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- October 24, 2010
- Report Date
- October 24, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS AND THE KEYPAD WAS OBSERVED TO BE INTACT WITH NO VISIBLE DAMAGE. THE "DOWN" ARROW BUTTON REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE FROM THE KEYPAD. THE "UP" AND "OK" BUTTONS WERE RESPONSIVE TO USER INPUT. ADDITIONALLY, THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE "DOWN" ARROW BUTTON CONTACT.
Description of Event or Problem · 1
THE PT'S MOTHER REPORTED THAT THE "DOWN" ARROW BUTTON WAS STICKING FROM THE KEYPAD. THE "DOWN" ARROW BUTTON HAD TO BE PRESSED MULTIPLE TIMES TO ELICIT A RESPONSE FROM THE KEYPAD. ALL OF THE BUTTONS BOUNCE AND SPRING BACK NORMALLY. THE REPORTER DENIES DAMAGE TO KEYPAD OR EXPOSURE TO MOISTURE AND CLEANING PRODUCTS.
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 | 12 YR |