FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1963986
·
Received January 12, 2011
Report
- Report Number
- 2531779-2011-00195
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- December 15, 2010
- Report Date
- December 15, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Removal / Correction Number
- 2531779-03/24/2010-003-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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 WHICH COULD NOT BE DUPLICATED DURING TESTING. DURING EVALUATION THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED.
Description of Event or Problem · 1
DURING EVALUATION THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ONE TOUCH PING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |