FDA Adverse Event Malfunction Summary report: N

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

MDR report key: 2033411 · Received March 23, 2011

Report

Report Number
2531779-2011-01840
Event Type
Malfunction
Date Received
March 23, 2011
Report Date
February 24, 2011
Manufacturer
ANIMAS CORPORATION
Product Code
LZG
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CT, US
Reporter Occupation
UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE PUMP HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT YET BEEN COMPLETED. WHEN EVAL IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE BUTTONS ARE STICKING. IT WAS REPORTED THERE IS NO SIGN OF DAMAGE TO THE KEYPAD.

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