FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2070104
·
Received April 27, 2011
Report
- Report Number
- 2531779-2011-02907
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 5, 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
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED A DAMAGED FORCE SENSOR FLEX WIRE. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING. (B)(4). MFR DATE 7/2010. (B)(6).
Description of Event or Problem · 1
PATIENT REPORTS PUMP DISPENSED INSULIN DURING LOAD CARTRIDGE PHASE.
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 |