FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 2110481
·
Received April 25, 2011
Report
- Report Number
- 2531779-2011-02798
- Event Type
- Malfunction
- Date Received
- April 25, 2011
- Report Date
- March 28, 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 EVAL. ALL KEYPAD BUTTONS DID NOT ACTIVATE DESIRED PUMP FUNCTIONS DURING TESTING. IT WAS ALSO OBSERVED THAT THE KEYPAD BUTTONS REQUIRED MULTIPLE PRESSES TO ACTIVATE A RESPONSE. IT WAS FOUND THAT THE OK BUTTON CONTACT WAS INVERTED AND STUCK. IT WAS ALSO FOUND THAT ALL THE BUTTON CONTACTS WERE MISALIGNED. THE BUTTONS DID NOT HAVE NORMAL SPRING BACK. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. IT WAS CONFIRMED THAT THE KEYPAD BUTTON SYMBOLS WERE WORN OFF.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PT'S MOM THAT ALL THE BUTTONS ARE SUDDENLY UNRESPONSIVE. IT WAS REPORTED THAT THERE IS NO KNOWN TRAUMA TO KEYPAD.
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 |