FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 2030737
·
Received March 22, 2011
Report
- Report Number
- 2531779-2011-01810
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Report Date
- February 23, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. DURING INVESTIGATION, IT WAS FOUND THAT ALL KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE BOLUS BUTTON WAS INTERMITTENTLY UNRESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. THE KEYPAD ADHESIVE WAS ALSO FOUND UNDER THE BOLUS BUTTON.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP SELF SUSPENDED AND THE PUMP IS INCREASINGLY UNRESPONSIVE TO ALL BUTTON PRESSES. IT WAS REPORTED THAT THERE IS NO EXPOSURE TO WATER OR DAMAGE TO 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 |