FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 2060754
·
Received April 8, 2011
Report
- Report Number
- 2531779-2011-02189
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- January 4, 2011
- Report Date
- March 4, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PATIENT REPORTED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS HAVE REQUIRED MULTIPLE PRESSES TO OBTAIN A RESPONSE FOR THE PAST 1 TO 2 MONTHS. HE NOTED THAT THE BUTTONS FEEL FLAT AND DO NOT SPRING BACK WHEN PRESSED. THE PATIENT CONFIRMED THAT THE RUBBER KEYPAD IS INTACT; STATED THAT THE PUMP IS NOT EXPOSED TO WATER OR CLEANING PRODUCTS; AND STATED THAT HE WEARS THE PUMP ON HIS PANTS WITH A CLIP.
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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |