Description of Event or Problem · 1
ASANTE CLINICAL MANAGER REPORTED THAT (B)(6) YEAR OLD FEMALE CUSTOMER CALLED CUSTOMER SERVICE LINE AT 5:30 A.M ON (B)(6) 2014. CUSTOMER HAD RECEIVED THE ALARM "PUMP ERROR DETACH AND RECONNECT PUMP BODY." CUSTOMER THEN CHANGED THE PUMP BODY, INSULIN CARTRIDGE, AND INFUSION SET TWO TIMES AND AGAIN RECEIVED THE ALARM BOTH TIMES. WHILE ON THE PHONE, ASANTE CLINICAL MANAGER HAD THE CUSTOMER AGAIN CHANGE HER PUMP BODY, INSULIN CARTRIDGE AND INFUSION SET FOR THE THIRD TIME SINCE THE ISSUE BEGAN AND CUSTOMER RECEIVED THE SAME ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 336 MG/DL. CUSTOMER LIVES IN (B)(6) BUT WAS ON A FAMILY VACATION IN (B)(6) FOR THE NEXT TWO WEEKS. SHE DID NOT HAVE ANY SYRINGES OR AN INSULIN PEN AVAILABLE TO MANAGE HER DIABETES SO SHE WAS ADVISED TO GO TO THE EMERGENCY DEPARTMENT IN ORDER TO OBTAIN INSULIN. CLINICAL MANAGER WAS UNABLE TO OBTAIN LOT NUMBERS FROM THE CUSTOMER AT THE TIME OF THE CALL AND INSTRUCTED CUSTOMER TO HOLD ONTO THE PUMP BODIES FOR CUSTOMER SERVICE TO FOLLOW-UP WITH HER. ASANTE MADE FOLLOW-UP CALL TO CUSTOMER AT APPROXIMATELY 11:30AM EST ON THE SAME DAY. CUSTOMER WAS STILL IN THE EMERGENCY ROOM RECEIVING INSULIN AT 6 UNITS PER HOUR. SHE STATED THAT HER BLOOD GLUCOSE LEVEL DID NOT SEEM TO BE GOING DOWN. SHE DID NOT HAVE THE PUMP OR SUPPLIES WITH HER, SO ASANTE WAS UNABLE TO VERIFY SERIAL AND LOT NUMBERS. ASANTE INFORMED CUSTOMER THAT SHE WOULD RECEIVE A REPLACEMENT CONTROLLER, PUMP BODY AND INFUSION SETS AND THAT THEY WOULD BE DELIVERED TO HER THE NEXT MORNING. ASANTE REQUESTED THE RETURN OF THE PRODUCT THAT GAVE HER THE ALARM. THE CUSTOMER WAS HAVING AN ISSUE OBTAINING INSULIN SUPPLY SINCE SHE IS NOT AT HOME AND ASANTE CLINICAL MANAGER WAS WORKING WITH HER ON THIS.