Description of Event or Problem · 0
"THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/04/2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE BLACK BOX INDICATES A TIME AND DATE RESET IN WITHIN TWO MINUTES OF POWER OFF. TIME AND DATE WAS ACCURATELY SET AT START OF INVESTIGATION. INVESTIGATORS PERFORMED PUMP REWIND, LOAD, AND PRIME WITH NO ALARMS. PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. EVALUATION REVEALED THAT THE PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. E1. INITIAL REPORTER: ANIMAS CORPORATION 200 LAWRENCE DRIVE WEST CHESTER, PA 19380-3428 US. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON 02/04/2013 WITH THE FOLLOWING FINDINGS. 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."