FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1983309
·
Received February 2, 2011
Report
- Report Number
- 2531779-2011-00683
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Report Date
- January 6, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. THE KEYPAD WAS FOUND TO BE INTACT WITH NO PEELING OR TEARS. THE PUMP WAS INTERMITTENTLY RESPONSIVE TO UP AND DOWN ARROW BUTTON PRESSES. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION. CONTAMINATION WAS OBSERVED UNDER THE OK, DOWN, AND UP ARROW BUTTON CONTACTS.
Description of Event or Problem · 1
THE PT CONTACTED ANIMAS ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PT CLAIMED THAT THE OK BUTTON REQUIRED SEVERAL PRESSES IN ORDER FOR THE PUMP TO RESPOND. THE PT DENIED THAT THE DEVICE WAS EXPOSED TO WATER OR THAT THE KEYPAD WAS PEELING. THE PT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE.
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 |