FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1870438
·
Received October 6, 2010
Report
- Report Number
- 2531779-2010-01477
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Report Date
- September 6, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ANIMAS REC'D THE PRODUCT FOR EVAL AND NOTED THE FOLLOWING INVESTIGATION RESULTS: THE LETTERING ON THE "OK" BUTTON HAS RUBBED OFF, NO DAMAGE WAS OBSERVED TO THE KEYPAD, THE BUTTONS RESPOND TO PRESSES INTERMITTENTLY. THE "UP" BUTTON CONTACT WAS FOUND TO BE MISALIGNED AND THERE WAS CONTAMINATION UNDER THE BUTTON CONTACTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE "DOWN" BUTTON IS STICKING AND THE "OK" SYMBOL IS WORN OFF. THE RPTR CLAIMED THAT SHE HAS TO PRESS THE BUTTON MULTIPLE TIMES FOR A RESPONSE. THE RPTR DENIED ANY 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 CORPORATION | ONE TOUCH PING | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |