FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1901603
·
Received November 10, 2010
Report
- Report Number
- 2531779-2010-02206
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 11, 2010
- Report Date
- October 11, 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 KEYPAD BUTTONS WERE INTERMITTENTLY RESPONDING TO USER INPUTS. THE KEYPAD WAS REMOVED AND ALL KEY CONTACTS WERE OBSERVED TO BE 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 UP ARROW BUTTON WAS NOT RESPONDING ON THE KEYPAD. THE REPORTER DENIES DAMAGE TO THE KEYPAD AND THE BUTTONS CLICK AND SPRING BACK.
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 | 27 YR |