FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2071143
·
Received April 27, 2011
Report
- Report Number
- 2531779-2011-02932
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Report Date
- March 29, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED CONTAMINATION UNDER ALL KEYPAD BUTTON CONTACTS. ALL KEYPAD BUTTONS INTERMITTENTLY ACTIVATED PUMP FUNCTIONS WHEN PRESSED.
Description of Event or Problem · 1
THE PATIENT'S MOTHER REPORTED THAT FOR SIX MONTHS THE UP AND DOWN ARROW BUTTONS HAVE BEEN SLOW TO ACTIVATE PUMP FUNCTIONS WHEN PRESSED. SHE REPORTS THAT THE BUTTONS WILL NO LONGER ACTIVATE PUMP FUNCTIONS AT ALL. SHE REPORTED THAT THE KEYPAD RUBBER WAS INTACT AND THE BUTTONS CLICKED AND SPRUNG BACK NORMALLY. SHE DENIED ANY EXPOSURE TO MOISTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | OTP GLUCOSE MGMT SYSTEM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR |