FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1901588
·
Received November 10, 2010
Report
- Report Number
- 2531779-2010-02196
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 12, 2010
- Report Date
- October 12, 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
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. ANIMAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THIS TIME OF RELEASE. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED. THE LOSS OF DETECTION HAS DUPLICATED DURING TESTING. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. INVESTIGATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS.
Description of Event or Problem · 1
THE PT REPORTED THAT THE PUMP PUSHING INSULIN OUT DURING THE LOAD STEP WITH EVERY SET CHANGE OVER THE LAST TWO WEEKS. HE CONFIRMED THAT HE WAS DISCONNECTED FOR ALL OF THESE SET CHANGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ANIMAS 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |