FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2123248
·
Received June 14, 2011
Report
- Report Number
- 2531779-2011-04126
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Report Date
- May 18, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE DOWN ARROW AND BOLUS BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS. THE BOLUS BUTTON WAS FOUND TO BE TORN. A TORN BOLUS BUTTON WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACT WHICH WILL NEGATIVELY IMPACT BUTTON FUNCTION.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THE DOWN ARROW AND AUDIO BOLUS BUTTONS ARE DIFFICULT TO PRESS AND REQUIRE MULTIPLE PRESSES TO RESPOND. THE PATIENT REPORTEDLY WORE THE PUMP ON THE OUTSIDE OF CLOTHING AND DID NOT CLEAN THE PUMP.
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 | 16 YR |