FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1904184
·
Received November 15, 2010
Report
- Report Number
- 2531779-2010-02272
- 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 EVALUATION REVEALED THAT THE KEYPAD APPEARED TO BE SWOLLEN. THE "DOWN" KEYPAD BUTTON WAS INTERMITTENTLY RESPONDING. 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 DOWN ARROW BUTTON WAS STICKING AND HAD TO BE PRESSED MULTIPLE TIMES TO ELICIT A RESPONSE FROM THE KEYPAD. 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 | 73 YR |