FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2083299
·
Received May 10, 2011
Report
- Report Number
- 2531779-2011-03214
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 8, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6). CORRECTION/REMOVAL REPORTING NUMBER: 2531779-03/24/2010-003-R. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED AN OUT OF CALIBRATION FORCE SENSOR AND CONTAMINATION ON THE FORCE SENSOR. PUMP WAS UNABLE TO DETECT CARTRIDGE DETECTION DURING TESTING.
Description of Event or Problem · 1
PUMP WAS RETURNED FOR A SHORT LOAD STEP CAUSING A LARGE PRIME VOLUME. DURING INVESTIGATION, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION.
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 | 11 |