FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 2041625
·
Received March 10, 2011
Report
- Report Number
- 2531779-2011-01473
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- January 11, 2011
- Report Date
- February 11, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. THE PUMP IS OUT OF WARRANTY, AND THE PT HAS CHOSEN TO CONTINUE USING THE PUMP AT THIS TIME. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A 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 PT REPORTED THAT THE DOWN ARROW AND OK BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST MONTH. SHE NOTED THAT THE BUTTONS SPRING BACK AS EXPECTED WHEN PRESSED. THE PT DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED THAT THE PUMP HAS BEEN EXPOSED TO MOISTURE; AND STATED THAT SHE WEARS THE PUMP ON HER WAIST.
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 | 37 YR |