FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1953905
·
Received December 15, 2010
Report
- Report Number
- 2531779-2010-02877
- Event Type
- Malfunction
- Date Received
- December 15, 2010
- Date of Event
- November 16, 2010
- Report Date
- November 16, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Removal / Correction Number
- 2531779-03/24/2010-003-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. ANIMAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED. THE LOSS OF CARTRIDGE DETECTION WAS INTERMITTENTLY DUPLICATED DURING TESTING. INVESTIGATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. THE FORCE SENSOR PLATE WAS FOUND TO BE DIMPLED AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.
Description of Event or Problem · 1
EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ANIMAS 2020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |