FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1882840
·
Received October 22, 2010
Report
- Report Number
- 2531779-2010-01859
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Report Date
- September 22, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
THE PT INDICATED AFTER HE WENT SWIMMING, THE PUMP REBOOTED AND NOW THE PUMP IS NO LONGER RESPONDING TO THE UP ARROW, DOWN ARROW, AND OK BUTTONS. THE KEYPAD IS INTACT AND NOT PEELING. WHILE TROUBLESHOOTING WITH THE ANIMAS REPRESENTATIVE, THE PT FOUND MOISTURE INSIDE THE PUMP.
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 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |