FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2153740
·
Received July 7, 2011
Report
- Report Number
- 2531779-2011-04769
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Report Date
- June 14, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. THE FOLLOWING WAS FOUND WITH THE SUBJECT PUMP. ALL KEYPAD BUTTONS WERE RESPONDING INTERMITTENTLY. PRODUCT ANALYSIS REMOVED THE KEYPAD AND FOUND ADHESIVE UNDER THE CONTACTS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.
Description of Event or Problem · 1
THE PATIENT CLAIMED THAT THE DOWN BUTTON REQUIRED SEVERAL PRESSES TO ACTIVATE THE DESIRED PUMP FUNCTIONS. THE KEYPAD IS REPORTEDLY INTACT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ONETOUCH PING INSULIN PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR |