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Description of Event or Problem

COMPLAINANT REPORTED THAT THEIR FAMILY MEMBER HAS BEEN HAVING A PROBLEM ASSOCIATED WITH THEIR INSULIN PUMP. PT HAS BEEN WEARING A PUMP FOR THE LAST 4 TO 5 YEARS. THEY HAVE BEEN EXPERIENCING FAILURE OF THE NEW PUMP THREE TIMES WHICH CAUSES THEIR BLOOD SUGAR TO SEVERELY ELEVATE ABOVE THE NORMAL RANGE OF 100 TO 120. THEIR BLOOD SUGAR READING WHEN THEY DISCOVERED THE PROBLEM WAS NEAR 500. THE PUMP GIVES AN ERROR 21 MESSAGE AND ERASES THE BASAL RATE SETTINGS. EACH TIME THIS HAPPENS, THE COMPLAINANT IS DIRECTED BY THE MANUFACTURER TO REPLACE THE BATTERIES SPECIFICALLY WITH AN ENERGIZER BATTERY. THE COMPANY SENT A NEW PUMP BY OVERNIGHT MAIL. A THIRD INCIDENT HAPPENED, WITH THE NEW PUMP SENT FROM THE COMPANY IN SEPTEMBER 2003. PT CALLED THE CUSTOMER SERVICE DEPARTMENT AND WAS TOLD THAT THE COMPANY WAS AWARE OF THE PROBLEM AND CONSIDERED THIS TO BE A "NUISANCE" PROBLEM AND NOT TAKEN AS CRITICAL.