FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1901619
·
Received November 10, 2010
Report
- Report Number
- 2531779-2010-02231
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Report Date
- October 13, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED TO BE INTACT (NO LIFTING OR PEELING), THE PUMP WAS INTERMITTENTLY RESPONDING TO KEYPAD BUTTON PRESSES, THE UP ARROW AND CONTRAST KEY CONTACTS WERE MISALIGNED, ALL KEY CONTACTS WERE INVERTED AND DID NOT ALWAYS SPRING BACK, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER ALL KEY CONTACTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP IS NOT ALWAYS RESPONDING TO THE DOWN ARROW BUTTON. THE PUMP REPORTEDLY HAS NOT BEEN EXPOSED TO WATER AND THE KEYPAD IS INTACT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.
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 |