FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1911917
·
Received November 24, 2010
Report
- Report Number
- 2531779-2010-02534
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- October 27, 2010
- Report Date
- October 27, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 INTACT WITH NO LIFTING OR PEELING. THE "UP" "DOWN" AND "OK" KEYPAD BUTTONS WERE INTERMITTENTLY RESPONDING. THE KEYPAD WAS REMOVED AND THE "UP" "DOWN" AND "OK" KEY CONTACTS BECAME INVERTED WHEN PRESSED 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" AND "DOWN" ARROW BUTTONS WERE INTERMITTENTLY RESPONDING ON THE KEYPAD. THE "OK" BUTTON DID CLICK AND SPRING BACK NORMALLY. THE REPORTER 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 CORP. | ONE TOUCH PING | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |