FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1912953
·
Received November 18, 2010
Report
- Report Number
- 2531779-2010-02371
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- October 19, 2010
- Report Date
- October 19, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS AND THE EVAL REVEALED THAT THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING. ALL OF THE KEYPAD BUTTONS WERE INTERMITTENTLY RESPONDING AND REQUIRED EXCESSIVE FORCE TO ACTIVATE. THE KEYPAD WAS REMOVED AND ALL OF THE KEY CONTACTS WERE INVERTED AND DID NOT ALWAYS SPRING BACK. THERE WAS ALSO EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.
Description of Event or Problem · 1
THE PT REPORTED THAT THE "OK" KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE AND WILL NO LONGER CLICK AND SPRING BACK. THE RPTR DENIES DAMAGE TO THE KEYPAD OR EXPOSURE TO MOISTURE.
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 |