FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1904187
·
Received November 15, 2010
Report
- Report Number
- 2531779-2010-02269
- Event Type
- Malfunction
- Date Received
- November 15, 2010
- Date of Event
- October 14, 2010
- Report Date
- October 14, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 DURING TESTING. THE KEYPAD WAS REMOVED AND ALL OF THE KEY CONTACTS WERE INVERTED AND DID NOT ALWAYS SPRING BACK. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.
Description of Event or Problem · 1
THE PT'S MOTHER REPORTED THAT THE UP AND DOWN ARROW BUTTONS HAVE TO BE PRESSED MULTIPLE TIMES TO ELICIT A RESPONSE FROM THE KEYPAD. THE BUTTONS DO NOT CLICK OR SPRING BACK. THE REPORTER DENIES DAMAGE TO THE KEYPAD OR EXPOSURE TO WATER.
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 | 15 YR |