FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1926029
·
Received November 24, 2010
Report
- Report Number
- 2531779-2010-02450
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- October 22, 2010
- Report Date
- October 22, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS AND THE EVAL REVEALED THAT THE KEYPAD APPEARED TO BE SWOLLEN. THE "UP" AND "DOWN" KEYPAD BUTTON WAS INTERMITTENTLY RESPONDING. THE KEYPAD WAS REMOVED AND THE KEY CONTACTS WERE MISALIGNED. THE "UP" "DOWN" AND "OK" KEY CONTACTS BECAME INVERTED WHEN PRESSED AND DID NOT ALWAYS SPRING BACK. THERE WAS ALSO EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.
Description of Event or Problem · 1
THE PT REPORTED THAT THE BUTTONS WERE INTERMITTENTLY RESPONDING ON THE KEYPAD. THE BUTTONS BOUNCE AND SPRING BACK BUT HAVE TO BE PRESSED MULTIPLE TIMES TO ELICIT A RESPONSE FROM THE KEYPAD. THE RPTR DENIES DAMAGE TO THE 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 CORPORATION | ANIMAS 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |