FDA Adverse Event Summary report: N

ANIMAS INSULIN INFUSION PUMP

MDR report key: 3972875 · Received August 1, 2014

Report

Report Number
2531779-2014-22063
Date Received
August 1, 2014
Report Date
July 23, 2014
Manufacturer
ANIMAS CORPORATION
Product Code
LZG
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

SUBMITTED: 08/01/2014, DEVICE EVALUATION: ON INVESTIGATION, THE DISPLAY WAS NOTED TO BE DIM, FADED AND DISCOLORED.

Description of Event or Problem · 1

THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014: A DIM, FADED, DISCOLORED DISPLAY SCREEN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
450643 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

Patients

Seq Age Sex Outcome Treatment
1