Description of Event or Problem · 1
I AM WRITING TODAY TO INFORM YOU OF SOME PROBLEMS I HAVE EXPERIENCED WITH MY ANIMAS ONE TOUCH PING INSULIN PUMP. ON (B)(6)2010, I WAS OUTDOORS AND THE WARNING MUSIC ON MY PUMP WENT OFF. I WAS UNABLE AT THAT TIME TO SEE WHAT THE PROBLEM WAS, AS THE PUMP'S SCREEN IS NOT READABLE OUTDOORS IN DIRECT OR INDIRECT SUN AND ALSO IN SOME SHADE. UPON ARRIVING HOME, INDOORS, WHERE I COULD SEE THE PUMP'S SCREEN, THE SCREEN WAS DISPLAYING THE WARNING MESSAGE, PUMP IS NOT PRIMED. NO DELIVERY. I WAS PERPLEXED, AS THE ONLY TIME YOU WOULD NEED TO PRIME THE PUMP IS WHEN THE INFUSION SET IS BEING CHANGED, AND THE PUMP IS PRIMED IN ORDER TO FEED THE INSULIN FROM THE CARTRIDGE INTO THE SET TUBING. I THEN CONTACTED THE CUSTOMER SERVICE DEPT AT ANIMAS CORPORATION AND SPOKE WITH (B)(4). I ASKED FOR THE REASON WHY I WOULD RECEIVE THIS PUMP NOT PRIMED, NO DELIVERY MESSAGE WHEN I WAS SIMPLY WEARING MY PUMP AND NOT CHANGING THE INFUSION SET. (B)(4) WAS UNABLE TO GIVE ME A DEFINITE REASON AS TO WHY THIS OCCURRED. (B)(4) FIRST INFORMED ME THAT THE PUMP MAY HAVE GOTTEN HOT. I TOLD HER THAT WAS IMPOSSIBLE AS THE TEMPERATURE OUTSIDE WAS NOT ABOVE 104 DEGREES FAHRENHEIT AND MY PUMP WAS PROTECTED. NEXT (B)(4) ASKED ME HOW MANY TIMES I CYCLED THE PLUNGER ON THE CARTRIDGE AND IF I TWISTED THE PLUNGER WHEN I CHANGED THE CARTRIDGE. I TOLD HER THAT I DID NOT TWIST THE PLUNGER AND THAT I CYCLED THE PLUNGER TWO OR THREE TIMES. (B)(4) TOLD ME I SHOULD ONLY BE CYCLING THE PLUNGER TWO TIMES. (B)(4) ASKED ME ABOUT THE VENTS ON MY PUMP AND WHETHER OR NOT THEY WERE OK. I SAW NO EVIDENCE OF THE VENTS BEING CLOGGED. (B)(4) GAVE ME NO FURTHER INSTRUCTIONS REGARDING MY PUMP'S VENTS. I WAS TOLD THAT THE PUMP IS NOT PRIMED, NO DELIVERY MESSAGE COULD HAVE APPEARED DUE TO A PRESSURIZATION PROBLEM. THIS DID NOT MAKE SENSE BECAUSE I HAVE NOT BEEN ON ANY AIRPLANES OR HELICOPTERS. I WAS TOLD THAT THE WARNING COULD HAVE BEEN CAUSED BY AIR BUBBLES. IF THIS WERE THE CASE, WHY THEN DID THE ALARM OCCLUSION DETECTED, NO DELIVERY, NOT APPEAR ON MY PUMP'S SCREEN? (B)(4) THEN TOLD ME THAT SOMETIMES THE CARTRIDGE IN THE PUMP WHICH CONTAINS THE INSULIN DOES NOT ALWAYS SET CORRECTLY ON THE PUMP'S PISTON ROD. I WAS SHOCKED AND SCARED. THIS WOULD MEAN THAT THE POSSIBILITIES WERE EXTREMELY HIGH THAT THE PISTON ROD COULD UNDER INFUSE OR OVER INFUSE THE PERSON WEARING THE PUMP. WHEN THE PUMP WAS MANUFACTURED, THE GLASS SCREEN IS BOWED OUT AND CURVED MAKING IT EASY TO CATCH THE PUMP ON SOMETHING WHICH CAN CAUSE A GOUGE IN THE SCREEN MAKING IT HARD TO READ. THIS HAPPENED TO ME. WHEN I CONTACTED ANIMAS TO ASK IF THEY WERE AWARE OF THIS PROBLEM, THEY TOLD ME YES AND THAT THEY WERE OFFERING PUMP OWNERS ONE, AND ONLY ONE, REPLACEMENT PUMP. I TOLD (B)(4) THAT I DID NOT FEEL COMFORTABLE WEARING AN INSULIN INFUSION PUMP THAT WAS MALFUNCTIONING, ESPECIALLY SINCE ANIMAS HAD NO REASONS TO OFFER ME. I WOULD EXPECT THE MANUFACTURER TO BE ABLE TO GIVE ME CONCRETE REASONS AND SOLUTIONS TO THESE PROBLEMS. I FEEL THAT MYSELF, AS WELL AS OTHERS COULD BE IN DANGER OF BEING OVER DOSED OR UNDER DOSED WITH INSULIN. IF THE PUMP IS NOT READABLE OUTSIDE, THIS ALSO COULD CAUSE MAJOR PROBLEMS. IF THEY ARE OFFERING ONE TOUCH PING WEARERS ONE REPLACEMENT PUMP FOR THE SCREEN NOT BEING SHAPED CORRECTLY, IT IS OBVIOUS THAT ANIMAS IS AWARE OF THIS PARTICULAR PROBLEM. I REALIZE THAT PROBLEMS WITH THESE DEVICES CAN OCCUR. HOWEVER, WHEN THE MANUFACTURER DOES NOT KNOW THE REASON WHY THE PROBLEMS ARE OCCURRING, THEN THE PRODUCT NEEDS TO BE RECALLED. I FEEL THAT MY LIFE, AS WELL AS OTHERS, ARE BEING PUT IN JEOPARDY BY WEARING A PUMP THAT IS NOT VISIBLE OUTDOORS AND ONE THAT COULD POSSIBLY OVER INFUSE OR UNDER INFUSE THE WEARER WITH INSULIN. THIS CAN RESULT IN DEATH. I GIVE MY PERMISSION FOR ANY EMPLOYEE OF THE FOOD AND DRUG ADMINISTRATION TO REVIEW MY RECORDS, INCLUDING TELEPHONE CONVERSATIONS, WHICH ANIMAS DOES RECORD, AT ANIMAS CORPORATION IN ORDER TO ASSIST IN AN INVESTIGATION.