FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1894209
·
Received November 2, 2010
Report
- Report Number
- 2531779-2010-02035
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Date of Event
- September 30, 2010
- Report Date
- September 30, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP #1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2010 WITH THE FOLLOWING FINDINGS: THE KEYPAD BUTTONS WERE FOUND TO BE RESPONDING APPROPRIATELY TO PRESSES. THE KEYPAD WAS REMOVED AND NO DEFECTS WERE FOUND TO THE BUTTON CONTACTS.
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
THE PT REPORTED THAT IT TOOK CONSTANT BUTTON PRESSES TO ACHIEVE A PUMP RESPONSE. HE REPORTS THAT THE ISSUE IS WORSENING AND SAYS THAT THE BUTTONS SOMETIMES STICK AND DON'T SPRING BACK. THE PT DENIES VISIBLE KEYPAD DAMAGE.
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 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |