Description of Event or Problem · 1
COMPLAINANT'S PUMP MALFUNCTIONED AND CAUSED A SERIOUS ADVERSE REACTION. HE PRIMED THE PUMP AND IT APPEARED TO BE WORKING PROPERLY, BUT LATER THAT DAY HE BEGAN EXPERIENCING FREQUENT URINATION, EXTREME THIRST, PAINS, AND SEVERE LEG PAINS. HE THEN REALIZED THAT THE PUMP HAD NOT BEEN DELIVERING INSULIN FOR AN EXTENDED PERIOD OF TIME (POSSIBLY 6-8 HOURS). WHEN HE TESTED HIS BLOOD SUGAR IT WAS ABOVE 600. THIS IS VERY HIGH, HIS BLOOD SUGAR SHOULD BE 135/140. HE ALSO HAD VERY HIGH KETONES IN HIS URINE. TO TREAT HIMSELF HE DRANK LOTS OF WATER FOR 5 HOURS AND KEPT GIVING HIMSELF BOLUS/10 UNIT MAX SHOTS OF INSULIN UNTIL HIS BLOOD SUGAR CAME DOWN. HE DIDN'T SEE A DOCTOR BECAUSE HE IS EXPERIENCED WITH DIABETES AND WAS ABLE TO BRING IT DOWN ON HIS OWN. HE BELIEVES THERE ARE TWO PROBLEMS WITH THE UNIT. 1) NO INSULIN CAME OUT OF THE INFUSION SET AND 2) THE PUMP DID NOT ALARM DUE TO THE BACK PRESSURE. THIS INDICATES A PROBLEM WITH BOTH THE INFUSION SET AND THE PUMP. WHEN HE CHANGED THE INFUSION SET IT WORKED, BUT STILL, THE PUMP DIDN'T ALARM DUE TO BACK PRESSURE. HE HAS BEEN A DIABETIC FOR 33 YEARS AND HE HAS NEVER EXPERIENCED BLOOD SUGAR THIS HIGH. HE BELIEVES THAT IF HE WASN'T AS EXPERIENCED WITH IT AS HE IS, HE WOULD HAVE ENDED UP IN THE HOSPITAL. WHEN HE CALLED MEDTRONIC THEY ACCUSED HIM OF DOING SOMETHING WRONG. HE HAS A FEW OTHER COMPLAINTS ABOUT THIS PRODUCT: OF EVERY BOX OF QUICK SET INFUSION SETS AT LEAST 2 OF THE 10 ARE BENT AND MUST BE DISCARDED; THE PUMP IS SUPPOSED TO BE WATERPROOF BUT IT ISN'T; THE PERSON HE SPOKE TO AT THE PRODUCT HELP LINE (1-800-646-4633) DID NOT SEEM FAMILIAR WITH DIABETES AND GAVE HIM ADVICE THAT COULD HAVE BEEN EVEN MORE HARMFUL; AND HE HAS HAD PROBLEMS WITH THESE PUMPS FOR YEARS-HE HAS GONE THROUGH 6 PUMPS IN 5 YEARS AND HE ONLY RECEIVES REMANUFACTURED PUMPS, NOT NEW ONES. HE BELIEVES THE FIRM ONLY "REMANUFACTURES" FOR THE PROBLEM REPORTED AND THEN SENDS THE UNIT OUT TO SOMEONE NEW, WITHOUT MAKING SURE THERE ARE NO OTHER PROBLEMS.