FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1882850
·
Received October 22, 2010
Report
- Report Number
- 2531779-2010-01796
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 21, 2010
- Report Date
- September 21, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. ALL KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO BUTTON PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS.
Description of Event or Problem · 1
THE PT REPORTED THAT FOR THE PAST 2 TO 3 WEEKS THE 'OK' 'UP' AND 'DOWN' BUTTONS HAVE BECOME INTERMITTENTLY UNRESPONSIVE. NO CHANGE IN ACTIVITY AND THE PT DENIES EXPOSING THE PUMP TO MOISTURE OR CLEANING PRODUCTS.
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 | 55 YR |