FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2083794
·
Received May 10, 2011
Report
- Report Number
- 2531779-2011-03318
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 11, 2011
- Report Date
- April 12, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6). THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT; HOWEVER, ALL BUTTONS WERE INTERMITTENTLY RESPONDING TO USER INPUTS AND STICKING WHEN PRESSED DURING TESTING AND THERE WAS EVIDENCE OF CONTAMINATION UNDER THE ALL KEY CONTACTS. KEYPAD WAS REMOVED AND IT WAS NOTED THAT THERE WAS AN ADHESIVE FOUND UNDERNEATH THE CONTACT.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED THAT THE UP AND DOWN BUTTONS WERE STICKING. THE PATIENT STOPPED USING THE PUMP AND STARTED USING MANUAL INSULIN INJECTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ANM 2020 INSULIN INFUSION PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |