FDA Adverse Event Injury Summary report: N

MEDTRONIC MINIMED

MDR report key: 844335 · Received April 27, 2007

Report

Report Number
MW1042739
Event Type
Injury
Date Received
April 27, 2007
Date of Event
April 26, 2007
Report Date
April 27, 2007
Manufacturer
MEDTRONIC MINIMED
Product Code
LZG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY DAUGHTER USED A MEDTRONIC PARADIGM 722 INSULIN PUMP. ON APRIL 26TH AND A WEEK EARLIER I WAS NOT ABLE TO PERFORM A MANUAL BOLUS -ACT- BUTTON WOULDN'T WORK. I PHONED MEDTRONIC PROMPTLY 10:30PM ON APRIL 26TH. I SPOKE WITH SOMEONE AT 24HR PUMP SUPPORT LINE. I TOLD THEM THIS HAD HAPPENED LAST WEEK AS WELL, THE ACT BUTTON WOULD NOT LET ME GIVE A BOLUS THEN IT WOULD LET ME AFTER SEVERAL ATTEMPTS. THE MEDTRONIC CONTACT AND I WALKED THROUGH THE PUMP AND AFTER SEVERAL ATTEMPTS TO BOLUS IT WORKED, PROBLEM SOLVED SHE SAID. I PROCEDED TO EXPLAIN TO HER THAT MY DAUGHTER HAS WORN THIS PUMP FOR ONE YEAR, ALSO HAS WORN A DISETRONIC PUMP FOR SIX YEARS, AND THAT I WOULD LIKE A REPLACEMENT PUMP SENT OUT AS SOON AS POSSIBLE, BECAUSE I KNOW THAT THIS IS NOT ACCEPTABLE. I KNOW AN INSULIN PUMP. SHE PUT ME ON, HOLD. WHEN SHE RETURNED SHE ASKED ME WHAT BATTERY I WAS USING IN MY DAUGHTER'S PUMP. AN ENERGIZER LITHIUM I TOLD HER. SHE INFORMED ME THAT I CAN ONLY USE A ENERGIZER AAA. OR THE PUMP COULD MALFUNCTION AND MANY PEOPLE HAVE CALLED WITH THE SAME PROBLEM. MEDTRONIC HANDBOOK FOR THE PARADIGM 722 PG. 135, IT IS RECOMMENDED THAT YOU USE A AAA ENERGIZER BATTERY, DO NOT USE A RECHARGEABLE OR CARBON ZINC BATTERY IN THE PUMP. I BELIEVE MEDTRONIC SHOULD HAVE NOTIFIED ME ABOUT THE BATTERIES, OR AT LEAST A REMINDER ABOUT PROPER BATTERY USE. WE HAVE USED THE ENERGIZER LITHIUM BATTERY FOR MONTHS. I'M OBVIOUSLY CONCERNED THAT THE PUMP HAS BEEN POSSIBLY MALFUNCTIONING IN OTHER AREAS THAT I NOW QUESTION. PUMPERS NEED TO BE AWARE. I HAVE NOT REC'D ANY NOTICE FROM MEDTRONIC CONCERNING THE BATTEIRES I SHOULD BE USING IN THE PUMP. THANK YOU FOR ALLOWING ME TO TELL YOU MY CONCERNS. AFTER SIX YEARS WITH DISETRONIC I FIND THAT THEIR CUSTOMER SERVICE IS HEAD AND SHOULDERS ABOVE THAT OF MEDTRONIC, MINIMED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC MINIMED PARADIGM 722 INSULIN PUMP LZG MEDTRONIC MINIMED FCC ID: 0H2712 *

Patients

Seq Age Sex Outcome Treatment
1 13 YR Other| S