FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1872151
·
Received October 12, 2010
Report
- Report Number
- 2531779-2010-01573
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Date of Event
- September 13, 2010
- Report Date
- September 13, 2010
- Manufacturer
- ANIMAS CORP
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. THE EVAL OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
THE REPORTER ALLEGED THAT THE PUMP WAS INTERMITTENTLY NOT RESPONSIVE TO PRESSING OF THE DOWN ARROW BUTTON. IN ADDITION, THE REPORTER CLAIMED THAT THE BUTTON WAS NOT CLICKING OR SPRINGING BACK NORMALLY. THE REPORTER DENIED ANY EXPOSURE OF THE DEVICE TO WATER. THE REPORTER ALSO DENIED THAT THE KEYPAD WAS PEELING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORP | IR 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |