FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1881302
·
Received October 18, 2010
Report
- Report Number
- 2531779-2010-01724
- Event Type
- Malfunction
- Date Received
- October 18, 2010
- Date of Event
- September 18, 2010
- Report Date
- September 18, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED THAT THE PUMP WAS INTERMITTENTLY RESPONDING TO UP ARROW BUTTON PRESSES. THE KEYPAD WAS ALSO FOUND TO BE TORN NEAR THE UP ARROW BUTTON. ALSO, THE UP ARROW BUTTON CONTACT WAS FOUND TO BE INVERTED.
Description of Event or Problem · 1
THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS NOT RESPONDING TO UP ARROW BUTTON PRESSES. THE PT CLAIMED THAT THE UP ARROW BUTTON WAS STUCK AND NOT SPRINGING BACK. HE ALSO CLAIMED THAT IT WOULD TAKE SEVERAL ATTEMPTS TO STOP PROGRAMMING. THE PT DENIED THAT THE DEVICE WAS EXPOSED TO WATER OR SUFFERED PHYSICAL DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ONE TOUCH PING | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |